Pain
Conditions
Keywords
Pain, Pain Injection
Brief summary
The primary objective of the study is to assess the safety and tolerability of single and multiple subcutaneous doses of OLP-1002 in healthy subjects.
Detailed description
The exploratory objectives of the study are to evaluate the pharmacodynamic effect of OLP-1002 following single subcutaneous doses in healthy volunteers using a capsaicin pain model, and to monitor the effects of a single subcutaneous doses of OLP-1002 on cardiac QT interval. Where possible, single and/or multiple subcutaneous dose pharmacokinetics of OLP-1002 in healthy subjects will be determined.
Interventions
DRUGOLP-1002 (Test): Part A, Single Ascending Dose
Subcutaneous Injection: 30 ng, 120 ng, 400 ng, 1.2 µg, 3 µg, 6 µg, 12 µg, 20 µg, 40 μg, 80 μg, 160 μg
DRUGOLP-1002 (Test): Part B, Multiple Ascending Dose
Subcutaneous Injection: 5 x 2 μg, 5 x 5 μg, 5 x 10 μg, 5 x 20 μg, 5 x 40 μg, 5 x 80 μg
OTHERPlacebo: Placebo Part A, Single Ascending Dose
Subcutaneous Injection: Placebo
OTHERPlacebo: Placebo Part B, Multiple Ascending Dose
Subcutaneous Injection: Placebo x 5
Sponsors
OliPass Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
double-blind
Intervention model description
This will be a double-blind, randomized, placebo-controlled, single and multiple subcutaneous dose study.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy male or females of any race, between 18 and 60 years of age, inclusive. * Body mass index between 18.0 and 28.0 kg/m², inclusive. * In good health, determined by no clinically significant findings from medical history, physical examination, single 12-lead electrocardiogram (resting heart rate \> 45 bpm and \< 90 bpm), vital signs measurements, and clinical laboratory evaluations (congenital nonhemolytic hyperbilirubinemia \[eg, suspicion of Gilbert's syndrome based on total and direct bilirubin\] is not acceptable) at Screening as assessed by the Investigator (or designee). * Willing to abide by the contraception requirements. * Able to comprehend and willing to sign an Informed Consent Form and to abide by the study restrictions.
Exclusion criteria
* Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the Investigator (or designee). * History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee). * Any of the following: * QT interval corrected for heart rate using Fridericia's method \> 450 ms confirmed by repeat measurement. * QRS duration \> 110 ms confirmed by repeat measurement. * PR interval \> 220 ms confirmed by repeat measurement. * findings which would make QT interval corrected for heart rate measurements difficult or QT interval corrected for heart rate data uninterpretable. * history of additional risk factors for torsades de pointes (eg, heart failure, hypokalemia, family history of long QT syndrome). * Female subjects who are pregnant or breastfeeding. * History of alcoholism or drug/chemical abuse within 1 year prior to Screening. * Alcohol consumption of \> 21 units per week for males and \>14 units per week for females. One unit of alcohol equals ½ pint (285 mL) of beer or lager, 1 glass (125 mL) of wine, or 1/6 gill (25 mL) of spirits. * Positive alcohol breath test result or positive urine drug screen (confirmed by repeat) at Screening or Check-in. * Positive hepatitis panel and/or positive human immunodeficiency virus test. * Active skin conditions such as dermatitis, allergy, eczema, psoriasis, or abnormal healing. * Tattoos, scars, or moles that in the opinion of the Investigator are likely to interfere with dosing or study assessments at any of the potential injection sites. * Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 90 days or 5 half-lives of the investigational product, whichever is longer, prior to Check-in. * Use or intend to use any medications/products known to alter drug absorption, metabolism, or elimination processes, including St. John's wort, within 30 days prior to Check-in, unless deemed acceptable by the Investigator (or designee). * Use or intend to use any prescription medications/products other than hormone replacement therapy, oral, implantable, transdermal, injectable, or intrauterine contraceptive concomitant medications within 14 days prior to Check-in, unless deemed acceptable by the Investigator (or designee). * Use or intend to use slow-release medications/products considered to still be active within 14 days prior to Check-in, unless deemed acceptable by the Investigator (or designee). * Use or intend to use any nonprescription medications/products including vitamins, minerals, and phytotherapeutic/herbal/plant-derived preparations within 7 days prior to Check-in, unless deemed acceptable by the Investigator (or designee) and/or Sponsor have given their prior consent. * Use of tobacco- or nicotine-containing products within 3 months prior to Check-in. * Receipt of blood products within 60 days prior to Check-in. * Donation of blood from 3 months prior to Screening, plasma from 2 weeks prior to Screening, or platelets from 6 weeks prior to Screening. * Poor peripheral venous access. * Have previously completed or withdrawn from this study or any other study investigating OLP-1002, and have previously received the investigational product. * Subjects who, in the opinion of the Investigator (or designee), should not participate in this study. * Part A - PD assessment groups only * Subjects considered non-acceptable responders to the intradermal capsaicin test at screening, defined as maximum VAS score of \< 3.0 or \> 9.0.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events Stratified by Overall and Severity | Part A: From screening through study completion, up to 32 days. Part B: From screening through study completion, up to 60 days. | Participants were observed for any signs or symptoms of adverse events and asked about their condition by open questioning, such as How have you been feeling since you were last asked?, at least once each day while resident at the study site and at each study visit. |
| Number of Participants Who Experienced Clinically Important Changes in Supine Diastolic and Systolic Blood Pressure | Part A: From screening through study completion, up to 32 days. Part B: From screening through study completion, up to 60 days. | Number of participants who experienced clinically important changes from baseline (the last value recorded prior to first dose) to scheduled timepoints in supine diastolic and systolic blood pressure. Participants were supine for at least 5 minutes before blood pressure measurements. Blood pressure was measured in triplicate and the time of measurement are below: Single ascending dose: Predose, 1, 2, 4, 8, 24 (± 1 hours), and 48 hours posdose Multiple ascending dose: Day 1 (Predose, 1, 2, 4, and 8 hours postdose), Day 2, Day 4 (postdose), Day 5, Day 7 (postdose), Day 9, Day 10 (postdose), Day 12, Day 13 (predose, 1, 2, 4, and 8 hours postdose), and Day 15 No treatment or dose related trends and no clinically significant changes were observed in mean or individual participant supine blood pressure. Supine diastolic blood pressure reference range: 90 to 140 mmHg. Supine systolic blood pressure reference range: 50 to 90 mmHg. |
| Number of Participants Who Experienced Clinically Important Changes in Supine Pulse Rate | Part A: From screening through study completion, up to 32 days. Part B: From screening through study completion, up to 60 days. | Number of participants who experienced clinically important changes from baseline (the last value recorded prior to first dose) to scheduled timepoints in supine pulse rate. Participants were supine for at least 5 minutes before pulse rate measurements. Pulse rate was measured in triplicate and the time of measurement are below: Single ascending dose: Predose, 1, 2, 4, 8, 24 (± 1 hours), and 48 hours posdose Multiple ascending dose: Day 1 (Predose, 1, 2, 4, and 8 hours postdose), Day 2, Day 4 (postdose), Day 5, Day 7 (postdose), Day 9, Day 10 (postdose), Day 12, Day 13 (predose, 1, 2, 4, and 8 hours postdose), and Day 15 No treatment or dose related trends and no clinically significant changes were observed in mean or individual participant supine pulse rate. Reference range: 40 to 100 beats per minute. |
| Number of Participants Who Experienced Clinically Important Changes in Respiratory Rate | Part A: From screening through study completion, up to 32 days. Part B: From screening through study completion, up to 60 days. | Number of participants who experienced clinically important changes from baseline (the last value recorded prior to first dose) to scheduled timepoints in respiratory rate. Participants were supine for at least 5 minutes before respiratory rate measurements. Respiratory rate was measured in triplicate and the time of measurement are below: Single ascending dose: Predose, 1, 2, 4, 8, 24 (± 1 hours), and 48 hours posdose Multiple ascending dose: Day 1 (Predose, 1, 2, 4, and 8 hours postdose), Day 2, Day 4 (postdose), Day 5, Day 7 (postdose), Day 9, Day 10 (postdose), Day 12, Day 13 (predose, 1, 2, 4, and 8 hours postdose), and Day 15 No treatment or dose related trends and no clinically significant changes were observed in mean or individual participant respiratory rate. Reference range: 10 to 24 breaths per minute. |
| 12-lead Electrocardiogram Parameters | Part A: From screening through study completion, up to 32 days. Part B: From screening through study completion, up to 60 days. | Resting 12-lead electrocardiogram parameters were recorded after the participant had been supine and at rest for at least 5 minutes. Baseline: the last value recorded prior to first dose; QTcB: QT interval corrected for heart rate using Bazett's formula; QTcF: QT interval corrected for heart rate using Fridericia's method. |
| Number of Participants With Findings of Clinical Importance in Clinical Chemistry, Hematology, and Urinalysis Test Results | Part A: From screening through study completion, up to 32 days. Part B: From screening through study completion, up to 60 days. | Number of participants with findings of clinical importance in clinical chemistry, hematology, and urinalysis test results. Clinical laboratory evaluations included: Clinical chemistry: Alanine aminotransferase; Albumin; Alkaline phosphatase; Aspartate aminotransferase; Calcium; Chloride; Cholesterol; Creatinine; Direct bilirubin; Gamma-glutamyl transferase; Glucose; Inorganic phosphate; Potassium; Sodium; Total bilirubin; Total protein; Urea Hematology: Hematocrit; Hemoglobin; Mean cell hemoglobin; Mean cell hemoglobin concentration; Mean cell volume; Platelet count; Red blood cell count; White blood cell count; White blood cell differential (Basophils; Eosinophils; Lymphocytes; Monocytes; Neutrophils) Urinalysis: Blood; Glucose; Ketones; pH; Protein; Specific gravity; Urobilinogen; Microscopic examination |
| Number of Participants With Full and Symptom-Directed Physical Examination Results | Part A: From screening through study completion, up to 32 days. Part B: From screening through study completion, up to 60 days. | A full physical examination and symptom-directed physical examinations were performed at specified timepoints. |
| Number of Participants With Injection Site Assessment Results | Part A: From screening through study completion, up to 32 days. Part B: From screening through study completion, up to 60 days. | Evaluation of the dosing site for the following: Pain: Grade 0 to 4 Redness (assessed by estimating the size of the red patch at the injection site across its widest point): Grade 0: 0-24 mm; Grade 1: 25-50 mm; Grade 2: 51-100 mm; Grade 3: More than 100 mm; Grade 4: Requires medical intervention greater than analgesia Swelling (assessed by estimating the size of the raised area around the injection site across its widest point): Grade 0: 0-24 mm; Grade 1: 25-50 mm and does not interfere with activity; Grade 2: 51-100 mm or interferes with activity; Grade 3: More than 100 mm and prevents daily activity; Grade 4: Requires medical intervention greater than analgesia Tenderness: Grade 0 to 4 Bruising and ulceration were evaluated as present or absent. |
| Number of Participants With Exposure to OLP-1002 That Exceeded Pre-define Exposure Limits From Non-clinical Studies | Part A: Day 1 postdose. Part B: Day 1 postdose and Day 13 postdose. | Participants were assessed to demonstrate that exposure to OLP-1002 did not exceed pre-defined exposure limits from non-clinical studies. Participants with temporary detected plasma concentrations between the low limit of detection \[0.2 ng/mL\] and lower limit of quantification \[1 ng/mL\] are presented in the results. |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Part A, Single Ascending Dose Placebo: Part A, Single Ascending Dose: Subcutaneous Injection: Placebo | 17 |
| 30 ng OLP-1002: Part A, Single Ascending Dose OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 30 ng | 3 |
| 120 ng OLP-1002: Part A, Single Ascending Dose OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 120 ng | 6 |
| 400 ng OLP-1002: Part A, Single Ascending Dose OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 400 ng | 3 |
| 1.2 µg OLP-1002: Part A, Single Ascending Dose OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 1.2 µg | 6 |
| 3 µg OLP-1002: Part A, Single Ascending Dose OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 3 µg | 3 |
| 6 µg OLP-1002: Part A, Single Ascending Dose OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 6 µg | 6 |
| 12 µg OLP-1002: Part A, Single Ascending Dose OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 12 µg | 3 |
| 20 µg OLP-1002: Part A, Single Ascending Dose OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 20 µg | 3 |
| 40 µg OLP-1002: Part A, Single Ascending Dose OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 40 µg | 6 |
| 80 µg OLP-1002: Part A, Single Ascending Dose OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 80 µg | 6 |
| 160 µg OLP-1002: Part A, Single Ascending Dose OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 160 µg | 6 |
| 5 x Placebo Part B, Multiple Ascending Dose Placebo: Part B, Multiple Ascending Dose: Subcutaneous Injection: Placebo x 5 | 12 |
| 5 x 2 μg OLP-1002: Part B, Multiple Ascending Dose OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 2 μg | 6 |
| 5 x 5 μg OLP-1002: Part B, Multiple Ascending Dose OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 5 μg | 6 |
| 5 x 10 μg OLP-1002: Part B, Multiple Ascending Dose OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 10 μg | 6 |
| 5 x 20 μg OLP-1002: Part B, Multiple Ascending Dose OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 20 μg | 6 |
| 5 x 40 μg OLP-1002: Part B, Multiple Ascending Dose OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 40 μg | 6 |
| 5 x 80 μg OLP-1002: Part B, Multiple Ascending Dose OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 80 μg | 6 |
| Total | 116 |
Baseline characteristics
| Characteristic | Placebo Part A, Single Ascending Dose | 30 ng OLP-1002: Part A, Single Ascending Dose | 120 ng OLP-1002: Part A, Single Ascending Dose | 400 ng OLP-1002: Part A, Single Ascending Dose | 1.2 µg OLP-1002: Part A, Single Ascending Dose | 3 µg OLP-1002: Part A, Single Ascending Dose | 6 µg OLP-1002: Part A, Single Ascending Dose | 12 µg OLP-1002: Part A, Single Ascending Dose | 20 µg OLP-1002: Part A, Single Ascending Dose | 40 µg OLP-1002: Part A, Single Ascending Dose | 80 µg OLP-1002: Part A, Single Ascending Dose | 160 µg OLP-1002: Part A, Single Ascending Dose | 5 x Placebo Part B, Multiple Ascending Dose | 5 x 2 μg OLP-1002: Part B, Multiple Ascending Dose | 5 x 5 μg OLP-1002: Part B, Multiple Ascending Dose | 5 x 10 μg OLP-1002: Part B, Multiple Ascending Dose | 5 x 20 μg OLP-1002: Part B, Multiple Ascending Dose | 5 x 40 μg OLP-1002: Part B, Multiple Ascending Dose | 5 x 80 μg OLP-1002: Part B, Multiple Ascending Dose | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | 36.2 years STANDARD_DEVIATION 12.25 | 35.7 years STANDARD_DEVIATION 11.55 | 36.3 years STANDARD_DEVIATION 10.44 | 37.0 years STANDARD_DEVIATION 11.27 | 37.0 years STANDARD_DEVIATION 14.25 | 44.0 years STANDARD_DEVIATION 12.17 | 33.8 years STANDARD_DEVIATION 11.97 | 34.0 years STANDARD_DEVIATION 2.65 | 52.3 years STANDARD_DEVIATION 6.35 | 43.7 years STANDARD_DEVIATION 15.25 | 40.8 years STANDARD_DEVIATION 11.27 | 43.5 years STANDARD_DEVIATION 12.71 | 39.7 years STANDARD_DEVIATION 10.75 | 35.7 years STANDARD_DEVIATION 13.6 | 34.8 years STANDARD_DEVIATION 13.7 | 41.0 years STANDARD_DEVIATION 8.72 | 42.5 years STANDARD_DEVIATION 11.31 | 37.3 years STANDARD_DEVIATION 15.37 | 33.3 years STANDARD_DEVIATION 13.92 | 38.4 years STANDARD_DEVIATION 11.91 |
| Body Mass Index | 24.54 kg/m^2 STANDARD_DEVIATION 2.41 | 22.73 kg/m^2 STANDARD_DEVIATION 3.585 | 24.60 kg/m^2 STANDARD_DEVIATION 2.649 | 23.73 kg/m^2 STANDARD_DEVIATION 4.136 | 23.45 kg/m^2 STANDARD_DEVIATION 2.421 | 25.63 kg/m^2 STANDARD_DEVIATION 2.003 | 24.10 kg/m^2 STANDARD_DEVIATION 1.439 | 23.73 kg/m^2 STANDARD_DEVIATION 0.551 | 24.17 kg/m^2 STANDARD_DEVIATION 2.335 | 24.43 kg/m^2 STANDARD_DEVIATION 2.942 | 24.37 kg/m^2 STANDARD_DEVIATION 1.279 | 24.95 kg/m^2 STANDARD_DEVIATION 2.513 | 24.73 kg/m^2 STANDARD_DEVIATION 1.512 | 23.95 kg/m^2 STANDARD_DEVIATION 1.925 | 23.53 kg/m^2 STANDARD_DEVIATION 2.642 | 22.70 kg/m^2 STANDARD_DEVIATION 2.321 | 23.57 kg/m^2 STANDARD_DEVIATION 1.941 | 23.70 kg/m^2 STANDARD_DEVIATION 2.7 | 24.18 kg/m^2 STANDARD_DEVIATION 2.78 | 24.13 kg/m^2 STANDARD_DEVIATION 2.24 |
| Body Weight | 75.74 kg STANDARD_DEVIATION 11.677 | 77.47 kg STANDARD_DEVIATION 20.4 | 77.32 kg STANDARD_DEVIATION 9.601 | 75.33 kg STANDARD_DEVIATION 18.23 | 70.78 kg STANDARD_DEVIATION 8.725 | 73.80 kg STANDARD_DEVIATION 0.624 | 73.17 kg STANDARD_DEVIATION 6.91 | 66.00 kg STANDARD_DEVIATION 4.513 | 72.53 kg STANDARD_DEVIATION 11.441 | 72.72 kg STANDARD_DEVIATION 9.353 | 76.20 kg STANDARD_DEVIATION 15.517 | 72.23 kg STANDARD_DEVIATION 9.673 | 77.61 kg STANDARD_DEVIATION 8.632 | 73.03 kg STANDARD_DEVIATION 14.719 | 73.03 kg STANDARD_DEVIATION 14.844 | 64.08 kg STANDARD_DEVIATION 9.853 | 70.88 kg STANDARD_DEVIATION 9.658 | 67.02 kg STANDARD_DEVIATION 13.707 | 75.65 kg STANDARD_DEVIATION 9.408 | 73.37 kg STANDARD_DEVIATION 11.061 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 17 Participants | 3 Participants | 6 Participants | 3 Participants | 6 Participants | 3 Participants | 6 Participants | 3 Participants | 3 Participants | 5 Participants | 6 Participants | 6 Participants | 12 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 115 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Height | 175.2 cm STANDARD_DEVIATION 9 | 183.3 cm STANDARD_DEVIATION 12.06 | 177.3 cm STANDARD_DEVIATION 6.89 | 177.3 cm STANDARD_DEVIATION 6.51 | 173.8 cm STANDARD_DEVIATION 8.89 | 170.0 cm STANDARD_DEVIATION 6 | 174.2 cm STANDARD_DEVIATION 7.99 | 166.7 cm STANDARD_DEVIATION 3.79 | 173.0 cm STANDARD_DEVIATION 12.17 | 172.7 cm STANDARD_DEVIATION 9.31 | 176.0 cm STANDARD_DEVIATION 15.31 | 170.0 cm STANDARD_DEVIATION 5.44 | 177.1 cm STANDARD_DEVIATION 10.59 | 174.0 cm STANDARD_DEVIATION 12.81 | 175.3 cm STANDARD_DEVIATION 9.71 | 167.7 cm STANDARD_DEVIATION 6.65 | 173.2 cm STANDARD_DEVIATION 6.71 | 167.7 cm STANDARD_DEVIATION 12.53 | 176.8 cm STANDARD_DEVIATION 4.31 | 174.0 cm STANDARD_DEVIATION 9.33 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 6 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 7 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 14 Participants | 3 Participants | 5 Participants | 3 Participants | 5 Participants | 3 Participants | 5 Participants | 2 Participants | 3 Participants | 5 Participants | 5 Participants | 6 Participants | 11 Participants | 4 Participants | 5 Participants | 4 Participants | 5 Participants | 6 Participants | 6 Participants | 100 Participants |
| Sex: Female, Male Female | 6 Participants | 1 Participants | 2 Participants | 0 Participants | 2 Participants | 0 Participants | 1 Participants | 2 Participants | 2 Participants | 2 Participants | 2 Participants | 1 Participants | 4 Participants | 3 Participants | 2 Participants | 3 Participants | 2 Participants | 4 Participants | 1 Participants | 40 Participants |
| Sex: Female, Male Male | 11 Participants | 2 Participants | 4 Participants | 3 Participants | 4 Participants | 3 Participants | 5 Participants | 1 Participants | 1 Participants | 4 Participants | 4 Participants | 5 Participants | 8 Participants | 3 Participants | 4 Participants | 3 Participants | 4 Participants | 2 Participants | 5 Participants | 76 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk | EG012 affected / at risk | EG013 affected / at risk | EG014 affected / at risk | EG015 affected / at risk | EG016 affected / at risk | EG017 affected / at risk | EG018 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 17 | 0 / 3 | 0 / 6 | 0 / 3 | 0 / 6 | 0 / 3 | 0 / 6 | 0 / 3 | 0 / 3 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 12 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 |
| other Total, other adverse events | 7 / 17 | 3 / 3 | 2 / 6 | 0 / 3 | 0 / 6 | 1 / 3 | 2 / 6 | 0 / 3 | 0 / 3 | 3 / 6 | 5 / 6 | 3 / 6 | 7 / 12 | 3 / 6 | 4 / 6 | 5 / 6 | 4 / 6 | 6 / 6 | 5 / 6 |
| serious Total, serious adverse events | 0 / 17 | 0 / 3 | 0 / 6 | 0 / 3 | 0 / 6 | 0 / 3 | 0 / 6 | 0 / 3 | 0 / 3 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 12 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 |
Outcome results
Primary
12-lead Electrocardiogram Parameters
Resting 12-lead electrocardiogram parameters were recorded after the participant had been supine and at rest for at least 5 minutes. Baseline: the last value recorded prior to first dose; QTcB: QT interval corrected for heart rate using Bazett's formula; QTcF: QT interval corrected for heart rate using Fridericia's method.
Time frame: Part A: From screening through study completion, up to 32 days. Part B: From screening through study completion, up to 60 days.
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo Part A, Single Ascending Dose | 12-lead Electrocardiogram Parameters | Maximum increase from baseline in QTcF greater than 30 milliseconds | 0 Participants |
| Placebo Part A, Single Ascending Dose | 12-lead Electrocardiogram Parameters | Maximum postdose QTcB greater than 450 milliseconds | 0 Participants |
| Placebo Part A, Single Ascending Dose | 12-lead Electrocardiogram Parameters | Maximum increase from baseline in QTcB greater than 30 milliseconds | 2 Participants |
| Placebo Part A, Single Ascending Dose | 12-lead Electrocardiogram Parameters | Maximum postdose QTcF greater than 450 milliseconds | 0 Participants |
| 30 ng OLP-1002: Part A, Single Ascending Dose | 12-lead Electrocardiogram Parameters | Maximum postdose QTcF greater than 450 milliseconds | 0 Participants |
| 30 ng OLP-1002: Part A, Single Ascending Dose | 12-lead Electrocardiogram Parameters | Maximum increase from baseline in QTcF greater than 30 milliseconds | 0 Participants |
| 30 ng OLP-1002: Part A, Single Ascending Dose | 12-lead Electrocardiogram Parameters | Maximum increase from baseline in QTcB greater than 30 milliseconds | 1 Participants |
| 30 ng OLP-1002: Part A, Single Ascending Dose | 12-lead Electrocardiogram Parameters | Maximum postdose QTcB greater than 450 milliseconds | 0 Participants |
| 120 ng OLP-1002: Part A, Single Ascending Dose | 12-lead Electrocardiogram Parameters | Maximum increase from baseline in QTcB greater than 30 milliseconds | 1 Participants |
| 120 ng OLP-1002: Part A, Single Ascending Dose | 12-lead Electrocardiogram Parameters | Maximum increase from baseline in QTcF greater than 30 milliseconds | 0 Participants |
| 120 ng OLP-1002: Part A, Single Ascending Dose | 12-lead Electrocardiogram Parameters | Maximum postdose QTcB greater than 450 milliseconds | 2 Participants |
| 120 ng OLP-1002: Part A, Single Ascending Dose | 12-lead Electrocardiogram Parameters | Maximum postdose QTcF greater than 450 milliseconds | 1 Participants |
| 400 ng OLP-1002: Part A, Single Ascending Dose | 12-lead Electrocardiogram Parameters | Maximum postdose QTcF greater than 450 milliseconds | 0 Participants |
| 400 ng OLP-1002: Part A, Single Ascending Dose | 12-lead Electrocardiogram Parameters | Maximum postdose QTcB greater than 450 milliseconds | 0 Participants |
| 400 ng OLP-1002: Part A, Single Ascending Dose | 12-lead Electrocardiogram Parameters | Maximum increase from baseline in QTcF greater than 30 milliseconds | 0 Participants |
| 400 ng OLP-1002: Part A, Single Ascending Dose | 12-lead Electrocardiogram Parameters | Maximum increase from baseline in QTcB greater than 30 milliseconds | 0 Participants |
| 1.2 µg OLP-1002: Part A, Single Ascending Dose | 12-lead Electrocardiogram Parameters | Maximum increase from baseline in QTcF greater than 30 milliseconds | 0 Participants |
| 1.2 µg OLP-1002: Part A, Single Ascending Dose | 12-lead Electrocardiogram Parameters | Maximum postdose QTcF greater than 450 milliseconds | 0 Participants |
| 1.2 µg OLP-1002: Part A, Single Ascending Dose | 12-lead Electrocardiogram Parameters | Maximum postdose QTcB greater than 450 milliseconds | 0 Participants |
| 1.2 µg OLP-1002: Part A, Single Ascending Dose | 12-lead Electrocardiogram Parameters | Maximum increase from baseline in QTcB greater than 30 milliseconds | 1 Participants |
| 3 µg OLP-1002: Part A, Single Ascending Dose | 12-lead Electrocardiogram Parameters | Maximum increase from baseline in QTcF greater than 30 milliseconds | 0 Participants |
| 3 µg OLP-1002: Part A, Single Ascending Dose | 12-lead Electrocardiogram Parameters | Maximum postdose QTcF greater than 450 milliseconds | 0 Participants |
| 3 µg OLP-1002: Part A, Single Ascending Dose | 12-lead Electrocardiogram Parameters | Maximum postdose QTcB greater than 450 milliseconds | 0 Participants |
| 3 µg OLP-1002: Part A, Single Ascending Dose | 12-lead Electrocardiogram Parameters | Maximum increase from baseline in QTcB greater than 30 milliseconds | 0 Participants |
| 6 µg OLP-1002: Part A, Single Ascending Dose | 12-lead Electrocardiogram Parameters | Maximum increase from baseline in QTcF greater than 30 milliseconds | 0 Participants |
| 6 µg OLP-1002: Part A, Single Ascending Dose | 12-lead Electrocardiogram Parameters | Maximum postdose QTcF greater than 450 milliseconds | 0 Participants |
| 6 µg OLP-1002: Part A, Single Ascending Dose | 12-lead Electrocardiogram Parameters | Maximum postdose QTcB greater than 450 milliseconds | 0 Participants |
| 6 µg OLP-1002: Part A, Single Ascending Dose | 12-lead Electrocardiogram Parameters | Maximum increase from baseline in QTcB greater than 30 milliseconds | 0 Participants |
| 12 µg OLP-1002: Part A, Single Ascending Dose | 12-lead Electrocardiogram Parameters | Maximum postdose QTcB greater than 450 milliseconds | 1 Participants |
| 12 µg OLP-1002: Part A, Single Ascending Dose | 12-lead Electrocardiogram Parameters | Maximum increase from baseline in QTcF greater than 30 milliseconds | 0 Participants |
| 12 µg OLP-1002: Part A, Single Ascending Dose | 12-lead Electrocardiogram Parameters | Maximum increase from baseline in QTcB greater than 30 milliseconds | 0 Participants |
| 12 µg OLP-1002: Part A, Single Ascending Dose | 12-lead Electrocardiogram Parameters | Maximum postdose QTcF greater than 450 milliseconds | 0 Participants |
| 20 µg OLP-1002: Part A, Single Ascending Dose | 12-lead Electrocardiogram Parameters | Maximum postdose QTcB greater than 450 milliseconds | 0 Participants |
| 20 µg OLP-1002: Part A, Single Ascending Dose | 12-lead Electrocardiogram Parameters | Maximum postdose QTcF greater than 450 milliseconds | 0 Participants |
| 20 µg OLP-1002: Part A, Single Ascending Dose | 12-lead Electrocardiogram Parameters | Maximum increase from baseline in QTcB greater than 30 milliseconds | 0 Participants |
| 20 µg OLP-1002: Part A, Single Ascending Dose | 12-lead Electrocardiogram Parameters | Maximum increase from baseline in QTcF greater than 30 milliseconds | 0 Participants |
| 40 µg OLP-1002: Part A, Single Ascending Dose | 12-lead Electrocardiogram Parameters | Maximum increase from baseline in QTcF greater than 30 milliseconds | 0 Participants |
| 40 µg OLP-1002: Part A, Single Ascending Dose | 12-lead Electrocardiogram Parameters | Maximum postdose QTcB greater than 450 milliseconds | 0 Participants |
| 40 µg OLP-1002: Part A, Single Ascending Dose | 12-lead Electrocardiogram Parameters | Maximum postdose QTcF greater than 450 milliseconds | 0 Participants |
| 40 µg OLP-1002: Part A, Single Ascending Dose | 12-lead Electrocardiogram Parameters | Maximum increase from baseline in QTcB greater than 30 milliseconds | 0 Participants |
| 80 µg OLP-1002: Part A, Single Ascending Dose | 12-lead Electrocardiogram Parameters | Maximum increase from baseline in QTcB greater than 30 milliseconds | 0 Participants |
| 80 µg OLP-1002: Part A, Single Ascending Dose | 12-lead Electrocardiogram Parameters | Maximum increase from baseline in QTcF greater than 30 milliseconds | 1 Participants |
| 80 µg OLP-1002: Part A, Single Ascending Dose | 12-lead Electrocardiogram Parameters | Maximum postdose QTcB greater than 450 milliseconds | 0 Participants |
| 80 µg OLP-1002: Part A, Single Ascending Dose | 12-lead Electrocardiogram Parameters | Maximum postdose QTcF greater than 450 milliseconds | 0 Participants |
| 160 µg OLP-1002: Part A, Single Ascending Dose | 12-lead Electrocardiogram Parameters | Maximum increase from baseline in QTcF greater than 30 milliseconds | 0 Participants |
| 160 µg OLP-1002: Part A, Single Ascending Dose | 12-lead Electrocardiogram Parameters | Maximum postdose QTcF greater than 450 milliseconds | 0 Participants |
| 160 µg OLP-1002: Part A, Single Ascending Dose | 12-lead Electrocardiogram Parameters | Maximum increase from baseline in QTcB greater than 30 milliseconds | 0 Participants |
| 160 µg OLP-1002: Part A, Single Ascending Dose | 12-lead Electrocardiogram Parameters | Maximum postdose QTcB greater than 450 milliseconds | 0 Participants |
| 5 x Placebo Part B, Multiple Ascending Dose | 12-lead Electrocardiogram Parameters | Maximum increase from baseline in QTcF greater than 30 milliseconds | 1 Participants |
| 5 x Placebo Part B, Multiple Ascending Dose | 12-lead Electrocardiogram Parameters | Maximum postdose QTcF greater than 450 milliseconds | 1 Participants |
| 5 x Placebo Part B, Multiple Ascending Dose | 12-lead Electrocardiogram Parameters | Maximum postdose QTcB greater than 450 milliseconds | 1 Participants |
| 5 x Placebo Part B, Multiple Ascending Dose | 12-lead Electrocardiogram Parameters | Maximum increase from baseline in QTcB greater than 30 milliseconds | 1 Participants |
| 5 x 2 μg OLP-1002: Part B, Multiple Ascending Dose | 12-lead Electrocardiogram Parameters | Maximum postdose QTcB greater than 450 milliseconds | 1 Participants |
| 5 x 2 μg OLP-1002: Part B, Multiple Ascending Dose | 12-lead Electrocardiogram Parameters | Maximum increase from baseline in QTcB greater than 30 milliseconds | 1 Participants |
| 5 x 2 μg OLP-1002: Part B, Multiple Ascending Dose | 12-lead Electrocardiogram Parameters | Maximum postdose QTcF greater than 450 milliseconds | 0 Participants |
| 5 x 2 μg OLP-1002: Part B, Multiple Ascending Dose | 12-lead Electrocardiogram Parameters | Maximum increase from baseline in QTcF greater than 30 milliseconds | 0 Participants |
| 5 x 5 μg OLP-1002: Part B, Multiple Ascending Dose | 12-lead Electrocardiogram Parameters | Maximum increase from baseline in QTcB greater than 30 milliseconds | 1 Participants |
| 5 x 5 μg OLP-1002: Part B, Multiple Ascending Dose | 12-lead Electrocardiogram Parameters | Maximum postdose QTcB greater than 450 milliseconds | 0 Participants |
| 5 x 5 μg OLP-1002: Part B, Multiple Ascending Dose | 12-lead Electrocardiogram Parameters | Maximum postdose QTcF greater than 450 milliseconds | 0 Participants |
| 5 x 5 μg OLP-1002: Part B, Multiple Ascending Dose | 12-lead Electrocardiogram Parameters | Maximum increase from baseline in QTcF greater than 30 milliseconds | 1 Participants |
| 5 x 10 μg OLP-1002: Part B, Multiple Ascending Dose | 12-lead Electrocardiogram Parameters | Maximum postdose QTcB greater than 450 milliseconds | 0 Participants |
| 5 x 10 μg OLP-1002: Part B, Multiple Ascending Dose | 12-lead Electrocardiogram Parameters | Maximum postdose QTcF greater than 450 milliseconds | 0 Participants |
| 5 x 10 μg OLP-1002: Part B, Multiple Ascending Dose | 12-lead Electrocardiogram Parameters | Maximum increase from baseline in QTcB greater than 30 milliseconds | 1 Participants |
| 5 x 10 μg OLP-1002: Part B, Multiple Ascending Dose | 12-lead Electrocardiogram Parameters | Maximum increase from baseline in QTcF greater than 30 milliseconds | 0 Participants |
| 5 x 20 μg OLP-1002: Part B, Multiple Ascending Dose | 12-lead Electrocardiogram Parameters | Maximum postdose QTcB greater than 450 milliseconds | 0 Participants |
| 5 x 20 μg OLP-1002: Part B, Multiple Ascending Dose | 12-lead Electrocardiogram Parameters | Maximum increase from baseline in QTcB greater than 30 milliseconds | 3 Participants |
| 5 x 20 μg OLP-1002: Part B, Multiple Ascending Dose | 12-lead Electrocardiogram Parameters | Maximum postdose QTcF greater than 450 milliseconds | 0 Participants |
| 5 x 20 μg OLP-1002: Part B, Multiple Ascending Dose | 12-lead Electrocardiogram Parameters | Maximum increase from baseline in QTcF greater than 30 milliseconds | 2 Participants |
| 5 x 40 μg OLP-1002: Part B, Multiple Ascending Dose | 12-lead Electrocardiogram Parameters | Maximum increase from baseline in QTcB greater than 30 milliseconds | 2 Participants |
| 5 x 40 μg OLP-1002: Part B, Multiple Ascending Dose | 12-lead Electrocardiogram Parameters | Maximum postdose QTcF greater than 450 milliseconds | 1 Participants |
| 5 x 40 μg OLP-1002: Part B, Multiple Ascending Dose | 12-lead Electrocardiogram Parameters | Maximum increase from baseline in QTcF greater than 30 milliseconds | 1 Participants |
| 5 x 40 μg OLP-1002: Part B, Multiple Ascending Dose | 12-lead Electrocardiogram Parameters | Maximum postdose QTcB greater than 450 milliseconds | 0 Participants |
| 5 x 80 μg OLP-1002: Part B, Multiple Ascending Dose | 12-lead Electrocardiogram Parameters | Maximum increase from baseline in QTcB greater than 30 milliseconds | 2 Participants |
| 5 x 80 μg OLP-1002: Part B, Multiple Ascending Dose | 12-lead Electrocardiogram Parameters | Maximum postdose QTcB greater than 450 milliseconds | 0 Participants |
| 5 x 80 μg OLP-1002: Part B, Multiple Ascending Dose | 12-lead Electrocardiogram Parameters | Maximum increase from baseline in QTcF greater than 30 milliseconds | 0 Participants |
| 5 x 80 μg OLP-1002: Part B, Multiple Ascending Dose | 12-lead Electrocardiogram Parameters | Maximum postdose QTcF greater than 450 milliseconds | 0 Participants |
Primary
Number of Participants Who Experienced Clinically Important Changes in Respiratory Rate
Number of participants who experienced clinically important changes from baseline (the last value recorded prior to first dose) to scheduled timepoints in respiratory rate. Participants were supine for at least 5 minutes before respiratory rate measurements. Respiratory rate was measured in triplicate and the time of measurement are below: Single ascending dose: Predose, 1, 2, 4, 8, 24 (± 1 hours), and 48 hours posdose Multiple ascending dose: Day 1 (Predose, 1, 2, 4, and 8 hours postdose), Day 2, Day 4 (postdose), Day 5, Day 7 (postdose), Day 9, Day 10 (postdose), Day 12, Day 13 (predose, 1, 2, 4, and 8 hours postdose), and Day 15 No treatment or dose related trends and no clinically significant changes were observed in mean or individual participant respiratory rate. Reference range: 10 to 24 breaths per minute.
Time frame: Part A: From screening through study completion, up to 32 days. Part B: From screening through study completion, up to 60 days.
Population: Safety Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo Part A, Single Ascending Dose | Number of Participants Who Experienced Clinically Important Changes in Respiratory Rate | 0 Participants |
| 30 ng OLP-1002: Part A, Single Ascending Dose | Number of Participants Who Experienced Clinically Important Changes in Respiratory Rate | 0 Participants |
| 120 ng OLP-1002: Part A, Single Ascending Dose | Number of Participants Who Experienced Clinically Important Changes in Respiratory Rate | 0 Participants |
| 400 ng OLP-1002: Part A, Single Ascending Dose | Number of Participants Who Experienced Clinically Important Changes in Respiratory Rate | 0 Participants |
| 1.2 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants Who Experienced Clinically Important Changes in Respiratory Rate | 0 Participants |
| 3 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants Who Experienced Clinically Important Changes in Respiratory Rate | 0 Participants |
| 6 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants Who Experienced Clinically Important Changes in Respiratory Rate | 0 Participants |
| 12 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants Who Experienced Clinically Important Changes in Respiratory Rate | 0 Participants |
| 20 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants Who Experienced Clinically Important Changes in Respiratory Rate | 0 Participants |
| 40 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants Who Experienced Clinically Important Changes in Respiratory Rate | 0 Participants |
| 80 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants Who Experienced Clinically Important Changes in Respiratory Rate | 0 Participants |
| 160 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants Who Experienced Clinically Important Changes in Respiratory Rate | 0 Participants |
| 5 x Placebo Part B, Multiple Ascending Dose | Number of Participants Who Experienced Clinically Important Changes in Respiratory Rate | 0 Participants |
| 5 x 2 μg OLP-1002: Part B, Multiple Ascending Dose | Number of Participants Who Experienced Clinically Important Changes in Respiratory Rate | 0 Participants |
| 5 x 5 μg OLP-1002: Part B, Multiple Ascending Dose | Number of Participants Who Experienced Clinically Important Changes in Respiratory Rate | 0 Participants |
| 5 x 10 μg OLP-1002: Part B, Multiple Ascending Dose | Number of Participants Who Experienced Clinically Important Changes in Respiratory Rate | 0 Participants |
| 5 x 20 μg OLP-1002: Part B, Multiple Ascending Dose | Number of Participants Who Experienced Clinically Important Changes in Respiratory Rate | 0 Participants |
| 5 x 40 μg OLP-1002: Part B, Multiple Ascending Dose | Number of Participants Who Experienced Clinically Important Changes in Respiratory Rate | 0 Participants |
| 5 x 80 μg OLP-1002: Part B, Multiple Ascending Dose | Number of Participants Who Experienced Clinically Important Changes in Respiratory Rate | 0 Participants |
Primary
Number of Participants Who Experienced Clinically Important Changes in Supine Diastolic and Systolic Blood Pressure
Number of participants who experienced clinically important changes from baseline (the last value recorded prior to first dose) to scheduled timepoints in supine diastolic and systolic blood pressure. Participants were supine for at least 5 minutes before blood pressure measurements. Blood pressure was measured in triplicate and the time of measurement are below: Single ascending dose: Predose, 1, 2, 4, 8, 24 (± 1 hours), and 48 hours posdose Multiple ascending dose: Day 1 (Predose, 1, 2, 4, and 8 hours postdose), Day 2, Day 4 (postdose), Day 5, Day 7 (postdose), Day 9, Day 10 (postdose), Day 12, Day 13 (predose, 1, 2, 4, and 8 hours postdose), and Day 15 No treatment or dose related trends and no clinically significant changes were observed in mean or individual participant supine blood pressure. Supine diastolic blood pressure reference range: 90 to 140 mmHg. Supine systolic blood pressure reference range: 50 to 90 mmHg.
Time frame: Part A: From screening through study completion, up to 32 days. Part B: From screening through study completion, up to 60 days.
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo Part A, Single Ascending Dose | Number of Participants Who Experienced Clinically Important Changes in Supine Diastolic and Systolic Blood Pressure | Diastolic blood pressure (mmHg) | 0 Participants |
| Placebo Part A, Single Ascending Dose | Number of Participants Who Experienced Clinically Important Changes in Supine Diastolic and Systolic Blood Pressure | Systolic blood pressure (mmHg) | 0 Participants |
| 30 ng OLP-1002: Part A, Single Ascending Dose | Number of Participants Who Experienced Clinically Important Changes in Supine Diastolic and Systolic Blood Pressure | Systolic blood pressure (mmHg) | 0 Participants |
| 30 ng OLP-1002: Part A, Single Ascending Dose | Number of Participants Who Experienced Clinically Important Changes in Supine Diastolic and Systolic Blood Pressure | Diastolic blood pressure (mmHg) | 0 Participants |
| 120 ng OLP-1002: Part A, Single Ascending Dose | Number of Participants Who Experienced Clinically Important Changes in Supine Diastolic and Systolic Blood Pressure | Systolic blood pressure (mmHg) | 0 Participants |
| 120 ng OLP-1002: Part A, Single Ascending Dose | Number of Participants Who Experienced Clinically Important Changes in Supine Diastolic and Systolic Blood Pressure | Diastolic blood pressure (mmHg) | 0 Participants |
| 400 ng OLP-1002: Part A, Single Ascending Dose | Number of Participants Who Experienced Clinically Important Changes in Supine Diastolic and Systolic Blood Pressure | Systolic blood pressure (mmHg) | 0 Participants |
| 400 ng OLP-1002: Part A, Single Ascending Dose | Number of Participants Who Experienced Clinically Important Changes in Supine Diastolic and Systolic Blood Pressure | Diastolic blood pressure (mmHg) | 0 Participants |
| 1.2 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants Who Experienced Clinically Important Changes in Supine Diastolic and Systolic Blood Pressure | Systolic blood pressure (mmHg) | 0 Participants |
| 1.2 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants Who Experienced Clinically Important Changes in Supine Diastolic and Systolic Blood Pressure | Diastolic blood pressure (mmHg) | 0 Participants |
| 3 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants Who Experienced Clinically Important Changes in Supine Diastolic and Systolic Blood Pressure | Diastolic blood pressure (mmHg) | 0 Participants |
| 3 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants Who Experienced Clinically Important Changes in Supine Diastolic and Systolic Blood Pressure | Systolic blood pressure (mmHg) | 0 Participants |
| 6 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants Who Experienced Clinically Important Changes in Supine Diastolic and Systolic Blood Pressure | Systolic blood pressure (mmHg) | 0 Participants |
| 6 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants Who Experienced Clinically Important Changes in Supine Diastolic and Systolic Blood Pressure | Diastolic blood pressure (mmHg) | 0 Participants |
| 12 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants Who Experienced Clinically Important Changes in Supine Diastolic and Systolic Blood Pressure | Diastolic blood pressure (mmHg) | 0 Participants |
| 12 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants Who Experienced Clinically Important Changes in Supine Diastolic and Systolic Blood Pressure | Systolic blood pressure (mmHg) | 0 Participants |
| 20 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants Who Experienced Clinically Important Changes in Supine Diastolic and Systolic Blood Pressure | Diastolic blood pressure (mmHg) | 0 Participants |
| 20 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants Who Experienced Clinically Important Changes in Supine Diastolic and Systolic Blood Pressure | Systolic blood pressure (mmHg) | 0 Participants |
| 40 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants Who Experienced Clinically Important Changes in Supine Diastolic and Systolic Blood Pressure | Diastolic blood pressure (mmHg) | 0 Participants |
| 40 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants Who Experienced Clinically Important Changes in Supine Diastolic and Systolic Blood Pressure | Systolic blood pressure (mmHg) | 0 Participants |
| 80 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants Who Experienced Clinically Important Changes in Supine Diastolic and Systolic Blood Pressure | Diastolic blood pressure (mmHg) | 0 Participants |
| 80 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants Who Experienced Clinically Important Changes in Supine Diastolic and Systolic Blood Pressure | Systolic blood pressure (mmHg) | 0 Participants |
| 160 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants Who Experienced Clinically Important Changes in Supine Diastolic and Systolic Blood Pressure | Systolic blood pressure (mmHg) | 0 Participants |
| 160 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants Who Experienced Clinically Important Changes in Supine Diastolic and Systolic Blood Pressure | Diastolic blood pressure (mmHg) | 0 Participants |
| 5 x Placebo Part B, Multiple Ascending Dose | Number of Participants Who Experienced Clinically Important Changes in Supine Diastolic and Systolic Blood Pressure | Diastolic blood pressure (mmHg) | 0 Participants |
| 5 x Placebo Part B, Multiple Ascending Dose | Number of Participants Who Experienced Clinically Important Changes in Supine Diastolic and Systolic Blood Pressure | Systolic blood pressure (mmHg) | 0 Participants |
| 5 x 2 μg OLP-1002: Part B, Multiple Ascending Dose | Number of Participants Who Experienced Clinically Important Changes in Supine Diastolic and Systolic Blood Pressure | Diastolic blood pressure (mmHg) | 0 Participants |
| 5 x 2 μg OLP-1002: Part B, Multiple Ascending Dose | Number of Participants Who Experienced Clinically Important Changes in Supine Diastolic and Systolic Blood Pressure | Systolic blood pressure (mmHg) | 0 Participants |
| 5 x 5 μg OLP-1002: Part B, Multiple Ascending Dose | Number of Participants Who Experienced Clinically Important Changes in Supine Diastolic and Systolic Blood Pressure | Systolic blood pressure (mmHg) | 0 Participants |
| 5 x 5 μg OLP-1002: Part B, Multiple Ascending Dose | Number of Participants Who Experienced Clinically Important Changes in Supine Diastolic and Systolic Blood Pressure | Diastolic blood pressure (mmHg) | 0 Participants |
| 5 x 10 μg OLP-1002: Part B, Multiple Ascending Dose | Number of Participants Who Experienced Clinically Important Changes in Supine Diastolic and Systolic Blood Pressure | Diastolic blood pressure (mmHg) | 0 Participants |
| 5 x 10 μg OLP-1002: Part B, Multiple Ascending Dose | Number of Participants Who Experienced Clinically Important Changes in Supine Diastolic and Systolic Blood Pressure | Systolic blood pressure (mmHg) | 0 Participants |
| 5 x 20 μg OLP-1002: Part B, Multiple Ascending Dose | Number of Participants Who Experienced Clinically Important Changes in Supine Diastolic and Systolic Blood Pressure | Systolic blood pressure (mmHg) | 0 Participants |
| 5 x 20 μg OLP-1002: Part B, Multiple Ascending Dose | Number of Participants Who Experienced Clinically Important Changes in Supine Diastolic and Systolic Blood Pressure | Diastolic blood pressure (mmHg) | 0 Participants |
| 5 x 40 μg OLP-1002: Part B, Multiple Ascending Dose | Number of Participants Who Experienced Clinically Important Changes in Supine Diastolic and Systolic Blood Pressure | Diastolic blood pressure (mmHg) | 0 Participants |
| 5 x 40 μg OLP-1002: Part B, Multiple Ascending Dose | Number of Participants Who Experienced Clinically Important Changes in Supine Diastolic and Systolic Blood Pressure | Systolic blood pressure (mmHg) | 0 Participants |
| 5 x 80 μg OLP-1002: Part B, Multiple Ascending Dose | Number of Participants Who Experienced Clinically Important Changes in Supine Diastolic and Systolic Blood Pressure | Diastolic blood pressure (mmHg) | 0 Participants |
| 5 x 80 μg OLP-1002: Part B, Multiple Ascending Dose | Number of Participants Who Experienced Clinically Important Changes in Supine Diastolic and Systolic Blood Pressure | Systolic blood pressure (mmHg) | 0 Participants |
Primary
Number of Participants Who Experienced Clinically Important Changes in Supine Pulse Rate
Number of participants who experienced clinically important changes from baseline (the last value recorded prior to first dose) to scheduled timepoints in supine pulse rate. Participants were supine for at least 5 minutes before pulse rate measurements. Pulse rate was measured in triplicate and the time of measurement are below: Single ascending dose: Predose, 1, 2, 4, 8, 24 (± 1 hours), and 48 hours posdose Multiple ascending dose: Day 1 (Predose, 1, 2, 4, and 8 hours postdose), Day 2, Day 4 (postdose), Day 5, Day 7 (postdose), Day 9, Day 10 (postdose), Day 12, Day 13 (predose, 1, 2, 4, and 8 hours postdose), and Day 15 No treatment or dose related trends and no clinically significant changes were observed in mean or individual participant supine pulse rate. Reference range: 40 to 100 beats per minute.
Time frame: Part A: From screening through study completion, up to 32 days. Part B: From screening through study completion, up to 60 days.
Population: Safety Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo Part A, Single Ascending Dose | Number of Participants Who Experienced Clinically Important Changes in Supine Pulse Rate | 0 Participants |
| 30 ng OLP-1002: Part A, Single Ascending Dose | Number of Participants Who Experienced Clinically Important Changes in Supine Pulse Rate | 0 Participants |
| 120 ng OLP-1002: Part A, Single Ascending Dose | Number of Participants Who Experienced Clinically Important Changes in Supine Pulse Rate | 0 Participants |
| 400 ng OLP-1002: Part A, Single Ascending Dose | Number of Participants Who Experienced Clinically Important Changes in Supine Pulse Rate | 0 Participants |
| 1.2 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants Who Experienced Clinically Important Changes in Supine Pulse Rate | 0 Participants |
| 3 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants Who Experienced Clinically Important Changes in Supine Pulse Rate | 0 Participants |
| 6 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants Who Experienced Clinically Important Changes in Supine Pulse Rate | 0 Participants |
| 12 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants Who Experienced Clinically Important Changes in Supine Pulse Rate | 0 Participants |
| 20 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants Who Experienced Clinically Important Changes in Supine Pulse Rate | 0 Participants |
| 40 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants Who Experienced Clinically Important Changes in Supine Pulse Rate | 0 Participants |
| 80 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants Who Experienced Clinically Important Changes in Supine Pulse Rate | 0 Participants |
| 160 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants Who Experienced Clinically Important Changes in Supine Pulse Rate | 0 Participants |
| 5 x Placebo Part B, Multiple Ascending Dose | Number of Participants Who Experienced Clinically Important Changes in Supine Pulse Rate | 0 Participants |
| 5 x 2 μg OLP-1002: Part B, Multiple Ascending Dose | Number of Participants Who Experienced Clinically Important Changes in Supine Pulse Rate | 0 Participants |
| 5 x 5 μg OLP-1002: Part B, Multiple Ascending Dose | Number of Participants Who Experienced Clinically Important Changes in Supine Pulse Rate | 0 Participants |
| 5 x 10 μg OLP-1002: Part B, Multiple Ascending Dose | Number of Participants Who Experienced Clinically Important Changes in Supine Pulse Rate | 0 Participants |
| 5 x 20 μg OLP-1002: Part B, Multiple Ascending Dose | Number of Participants Who Experienced Clinically Important Changes in Supine Pulse Rate | 0 Participants |
| 5 x 40 μg OLP-1002: Part B, Multiple Ascending Dose | Number of Participants Who Experienced Clinically Important Changes in Supine Pulse Rate | 0 Participants |
| 5 x 80 μg OLP-1002: Part B, Multiple Ascending Dose | Number of Participants Who Experienced Clinically Important Changes in Supine Pulse Rate | 0 Participants |
Primary
Number of Participants With Adverse Events Stratified by Overall and Severity
Participants were observed for any signs or symptoms of adverse events and asked about their condition by open questioning, such as How have you been feeling since you were last asked?, at least once each day while resident at the study site and at each study visit.
Time frame: Part A: From screening through study completion, up to 32 days. Part B: From screening through study completion, up to 60 days.
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo Part A, Single Ascending Dose | Number of Participants With Adverse Events Stratified by Overall and Severity | Treatment-emergent adverse events (Overall) | 7 Participants |
| Placebo Part A, Single Ascending Dose | Number of Participants With Adverse Events Stratified by Overall and Severity | Moderate | 1 Participants |
| Placebo Part A, Single Ascending Dose | Number of Participants With Adverse Events Stratified by Overall and Severity | Mild | 6 Participants |
| Placebo Part A, Single Ascending Dose | Number of Participants With Adverse Events Stratified by Overall and Severity | Severe | 0 Participants |
| 30 ng OLP-1002: Part A, Single Ascending Dose | Number of Participants With Adverse Events Stratified by Overall and Severity | Moderate | 0 Participants |
| 30 ng OLP-1002: Part A, Single Ascending Dose | Number of Participants With Adverse Events Stratified by Overall and Severity | Severe | 0 Participants |
| 30 ng OLP-1002: Part A, Single Ascending Dose | Number of Participants With Adverse Events Stratified by Overall and Severity | Treatment-emergent adverse events (Overall) | 3 Participants |
| 30 ng OLP-1002: Part A, Single Ascending Dose | Number of Participants With Adverse Events Stratified by Overall and Severity | Mild | 3 Participants |
| 120 ng OLP-1002: Part A, Single Ascending Dose | Number of Participants With Adverse Events Stratified by Overall and Severity | Mild | 2 Participants |
| 120 ng OLP-1002: Part A, Single Ascending Dose | Number of Participants With Adverse Events Stratified by Overall and Severity | Treatment-emergent adverse events (Overall) | 2 Participants |
| 120 ng OLP-1002: Part A, Single Ascending Dose | Number of Participants With Adverse Events Stratified by Overall and Severity | Severe | 0 Participants |
| 120 ng OLP-1002: Part A, Single Ascending Dose | Number of Participants With Adverse Events Stratified by Overall and Severity | Moderate | 0 Participants |
| 400 ng OLP-1002: Part A, Single Ascending Dose | Number of Participants With Adverse Events Stratified by Overall and Severity | Moderate | 0 Participants |
| 400 ng OLP-1002: Part A, Single Ascending Dose | Number of Participants With Adverse Events Stratified by Overall and Severity | Treatment-emergent adverse events (Overall) | 0 Participants |
| 400 ng OLP-1002: Part A, Single Ascending Dose | Number of Participants With Adverse Events Stratified by Overall and Severity | Severe | 0 Participants |
| 400 ng OLP-1002: Part A, Single Ascending Dose | Number of Participants With Adverse Events Stratified by Overall and Severity | Mild | 0 Participants |
| 1.2 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Adverse Events Stratified by Overall and Severity | Mild | 0 Participants |
| 1.2 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Adverse Events Stratified by Overall and Severity | Moderate | 0 Participants |
| 1.2 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Adverse Events Stratified by Overall and Severity | Severe | 0 Participants |
| 1.2 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Adverse Events Stratified by Overall and Severity | Treatment-emergent adverse events (Overall) | 0 Participants |
| 3 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Adverse Events Stratified by Overall and Severity | Severe | 0 Participants |
| 3 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Adverse Events Stratified by Overall and Severity | Treatment-emergent adverse events (Overall) | 1 Participants |
| 3 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Adverse Events Stratified by Overall and Severity | Moderate | 0 Participants |
| 3 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Adverse Events Stratified by Overall and Severity | Mild | 1 Participants |
| 6 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Adverse Events Stratified by Overall and Severity | Moderate | 0 Participants |
| 6 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Adverse Events Stratified by Overall and Severity | Severe | 0 Participants |
| 6 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Adverse Events Stratified by Overall and Severity | Treatment-emergent adverse events (Overall) | 2 Participants |
| 6 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Adverse Events Stratified by Overall and Severity | Mild | 2 Participants |
| 12 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Adverse Events Stratified by Overall and Severity | Severe | 0 Participants |
| 12 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Adverse Events Stratified by Overall and Severity | Treatment-emergent adverse events (Overall) | 0 Participants |
| 12 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Adverse Events Stratified by Overall and Severity | Moderate | 0 Participants |
| 12 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Adverse Events Stratified by Overall and Severity | Mild | 0 Participants |
| 20 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Adverse Events Stratified by Overall and Severity | Moderate | 0 Participants |
| 20 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Adverse Events Stratified by Overall and Severity | Severe | 0 Participants |
| 20 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Adverse Events Stratified by Overall and Severity | Mild | 0 Participants |
| 20 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Adverse Events Stratified by Overall and Severity | Treatment-emergent adverse events (Overall) | 0 Participants |
| 40 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Adverse Events Stratified by Overall and Severity | Severe | 0 Participants |
| 40 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Adverse Events Stratified by Overall and Severity | Mild | 2 Participants |
| 40 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Adverse Events Stratified by Overall and Severity | Moderate | 1 Participants |
| 40 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Adverse Events Stratified by Overall and Severity | Treatment-emergent adverse events (Overall) | 3 Participants |
| 80 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Adverse Events Stratified by Overall and Severity | Treatment-emergent adverse events (Overall) | 5 Participants |
| 80 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Adverse Events Stratified by Overall and Severity | Mild | 5 Participants |
| 80 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Adverse Events Stratified by Overall and Severity | Moderate | 1 Participants |
| 80 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Adverse Events Stratified by Overall and Severity | Severe | 0 Participants |
| 160 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Adverse Events Stratified by Overall and Severity | Mild | 3 Participants |
| 160 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Adverse Events Stratified by Overall and Severity | Moderate | 0 Participants |
| 160 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Adverse Events Stratified by Overall and Severity | Treatment-emergent adverse events (Overall) | 3 Participants |
| 160 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Adverse Events Stratified by Overall and Severity | Severe | 0 Participants |
| 5 x Placebo Part B, Multiple Ascending Dose | Number of Participants With Adverse Events Stratified by Overall and Severity | Severe | 0 Participants |
| 5 x Placebo Part B, Multiple Ascending Dose | Number of Participants With Adverse Events Stratified by Overall and Severity | Treatment-emergent adverse events (Overall) | 7 Participants |
| 5 x Placebo Part B, Multiple Ascending Dose | Number of Participants With Adverse Events Stratified by Overall and Severity | Mild | 7 Participants |
| 5 x Placebo Part B, Multiple Ascending Dose | Number of Participants With Adverse Events Stratified by Overall and Severity | Moderate | 1 Participants |
| 5 x 2 μg OLP-1002: Part B, Multiple Ascending Dose | Number of Participants With Adverse Events Stratified by Overall and Severity | Moderate | 0 Participants |
| 5 x 2 μg OLP-1002: Part B, Multiple Ascending Dose | Number of Participants With Adverse Events Stratified by Overall and Severity | Treatment-emergent adverse events (Overall) | 3 Participants |
| 5 x 2 μg OLP-1002: Part B, Multiple Ascending Dose | Number of Participants With Adverse Events Stratified by Overall and Severity | Mild | 3 Participants |
| 5 x 2 μg OLP-1002: Part B, Multiple Ascending Dose | Number of Participants With Adverse Events Stratified by Overall and Severity | Severe | 0 Participants |
| 5 x 5 μg OLP-1002: Part B, Multiple Ascending Dose | Number of Participants With Adverse Events Stratified by Overall and Severity | Mild | 4 Participants |
| 5 x 5 μg OLP-1002: Part B, Multiple Ascending Dose | Number of Participants With Adverse Events Stratified by Overall and Severity | Severe | 0 Participants |
| 5 x 5 μg OLP-1002: Part B, Multiple Ascending Dose | Number of Participants With Adverse Events Stratified by Overall and Severity | Moderate | 0 Participants |
| 5 x 5 μg OLP-1002: Part B, Multiple Ascending Dose | Number of Participants With Adverse Events Stratified by Overall and Severity | Treatment-emergent adverse events (Overall) | 4 Participants |
| 5 x 10 μg OLP-1002: Part B, Multiple Ascending Dose | Number of Participants With Adverse Events Stratified by Overall and Severity | Treatment-emergent adverse events (Overall) | 5 Participants |
| 5 x 10 μg OLP-1002: Part B, Multiple Ascending Dose | Number of Participants With Adverse Events Stratified by Overall and Severity | Moderate | 1 Participants |
| 5 x 10 μg OLP-1002: Part B, Multiple Ascending Dose | Number of Participants With Adverse Events Stratified by Overall and Severity | Severe | 0 Participants |
| 5 x 10 μg OLP-1002: Part B, Multiple Ascending Dose | Number of Participants With Adverse Events Stratified by Overall and Severity | Mild | 4 Participants |
| 5 x 20 μg OLP-1002: Part B, Multiple Ascending Dose | Number of Participants With Adverse Events Stratified by Overall and Severity | Treatment-emergent adverse events (Overall) | 4 Participants |
| 5 x 20 μg OLP-1002: Part B, Multiple Ascending Dose | Number of Participants With Adverse Events Stratified by Overall and Severity | Moderate | 2 Participants |
| 5 x 20 μg OLP-1002: Part B, Multiple Ascending Dose | Number of Participants With Adverse Events Stratified by Overall and Severity | Mild | 3 Participants |
| 5 x 20 μg OLP-1002: Part B, Multiple Ascending Dose | Number of Participants With Adverse Events Stratified by Overall and Severity | Severe | 0 Participants |
| 5 x 40 μg OLP-1002: Part B, Multiple Ascending Dose | Number of Participants With Adverse Events Stratified by Overall and Severity | Severe | 0 Participants |
| 5 x 40 μg OLP-1002: Part B, Multiple Ascending Dose | Number of Participants With Adverse Events Stratified by Overall and Severity | Moderate | 1 Participants |
| 5 x 40 μg OLP-1002: Part B, Multiple Ascending Dose | Number of Participants With Adverse Events Stratified by Overall and Severity | Treatment-emergent adverse events (Overall) | 6 Participants |
| 5 x 40 μg OLP-1002: Part B, Multiple Ascending Dose | Number of Participants With Adverse Events Stratified by Overall and Severity | Mild | 6 Participants |
| 5 x 80 μg OLP-1002: Part B, Multiple Ascending Dose | Number of Participants With Adverse Events Stratified by Overall and Severity | Moderate | 0 Participants |
| 5 x 80 μg OLP-1002: Part B, Multiple Ascending Dose | Number of Participants With Adverse Events Stratified by Overall and Severity | Severe | 0 Participants |
| 5 x 80 μg OLP-1002: Part B, Multiple Ascending Dose | Number of Participants With Adverse Events Stratified by Overall and Severity | Mild | 5 Participants |
| 5 x 80 μg OLP-1002: Part B, Multiple Ascending Dose | Number of Participants With Adverse Events Stratified by Overall and Severity | Treatment-emergent adverse events (Overall) | 5 Participants |
Primary
Number of Participants With Exposure to OLP-1002 That Exceeded Pre-define Exposure Limits From Non-clinical Studies
Participants were assessed to demonstrate that exposure to OLP-1002 did not exceed pre-defined exposure limits from non-clinical studies. Participants with temporary detected plasma concentrations between the low limit of detection \[0.2 ng/mL\] and lower limit of quantification \[1 ng/mL\] are presented in the results.
Time frame: Part A: Day 1 postdose. Part B: Day 1 postdose and Day 13 postdose.
Population: Safety Population.~Plasma concentrations of OLP-1002 were not analyzed for the groups receiving single doses of 30 ng, 120 ng, 400 ng, 1.2 µg, and 3 µg OLP-1002 and were assumed also to be below the lower limit of quantification/limit of detection. Day 13 assessments were not applicable for Part A of the study.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo Part A, Single Ascending Dose | Number of Participants With Exposure to OLP-1002 That Exceeded Pre-define Exposure Limits From Non-clinical Studies | Day 1 Postdose | 0 Participants |
| 30 ng OLP-1002: Part A, Single Ascending Dose | Number of Participants With Exposure to OLP-1002 That Exceeded Pre-define Exposure Limits From Non-clinical Studies | Day 1 Postdose | 0 Participants |
| 120 ng OLP-1002: Part A, Single Ascending Dose | Number of Participants With Exposure to OLP-1002 That Exceeded Pre-define Exposure Limits From Non-clinical Studies | Day 1 Postdose | 0 Participants |
| 400 ng OLP-1002: Part A, Single Ascending Dose | Number of Participants With Exposure to OLP-1002 That Exceeded Pre-define Exposure Limits From Non-clinical Studies | Day 1 Postdose | 4 Participants |
| 1.2 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Exposure to OLP-1002 That Exceeded Pre-define Exposure Limits From Non-clinical Studies | Day 1 Postdose | 6 Participants |
| 3 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Exposure to OLP-1002 That Exceeded Pre-define Exposure Limits From Non-clinical Studies | Day 13 Postdose | 0 Participants |
| 3 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Exposure to OLP-1002 That Exceeded Pre-define Exposure Limits From Non-clinical Studies | Day 1 Postdose | 0 Participants |
| 6 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Exposure to OLP-1002 That Exceeded Pre-define Exposure Limits From Non-clinical Studies | Day 1 Postdose | 0 Participants |
| 6 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Exposure to OLP-1002 That Exceeded Pre-define Exposure Limits From Non-clinical Studies | Day 13 Postdose | 0 Participants |
| 12 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Exposure to OLP-1002 That Exceeded Pre-define Exposure Limits From Non-clinical Studies | Day 1 Postdose | 0 Participants |
| 12 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Exposure to OLP-1002 That Exceeded Pre-define Exposure Limits From Non-clinical Studies | Day 13 Postdose | 0 Participants |
| 20 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Exposure to OLP-1002 That Exceeded Pre-define Exposure Limits From Non-clinical Studies | Day 1 Postdose | 0 Participants |
| 20 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Exposure to OLP-1002 That Exceeded Pre-define Exposure Limits From Non-clinical Studies | Day 13 Postdose | 0 Participants |
| 40 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Exposure to OLP-1002 That Exceeded Pre-define Exposure Limits From Non-clinical Studies | Day 1 Postdose | 3 Participants |
| 40 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Exposure to OLP-1002 That Exceeded Pre-define Exposure Limits From Non-clinical Studies | Day 13 Postdose | 3 Participants |
| 80 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Exposure to OLP-1002 That Exceeded Pre-define Exposure Limits From Non-clinical Studies | Day 13 Postdose | 5 Participants |
| 80 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Exposure to OLP-1002 That Exceeded Pre-define Exposure Limits From Non-clinical Studies | Day 1 Postdose | 6 Participants |
Primary
Number of Participants With Findings of Clinical Importance in Clinical Chemistry, Hematology, and Urinalysis Test Results
Number of participants with findings of clinical importance in clinical chemistry, hematology, and urinalysis test results. Clinical laboratory evaluations included: Clinical chemistry: Alanine aminotransferase; Albumin; Alkaline phosphatase; Aspartate aminotransferase; Calcium; Chloride; Cholesterol; Creatinine; Direct bilirubin; Gamma-glutamyl transferase; Glucose; Inorganic phosphate; Potassium; Sodium; Total bilirubin; Total protein; Urea Hematology: Hematocrit; Hemoglobin; Mean cell hemoglobin; Mean cell hemoglobin concentration; Mean cell volume; Platelet count; Red blood cell count; White blood cell count; White blood cell differential (Basophils; Eosinophils; Lymphocytes; Monocytes; Neutrophils) Urinalysis: Blood; Glucose; Ketones; pH; Protein; Specific gravity; Urobilinogen; Microscopic examination
Time frame: Part A: From screening through study completion, up to 32 days. Part B: From screening through study completion, up to 60 days.
Population: Safety Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo Part A, Single Ascending Dose | Number of Participants With Findings of Clinical Importance in Clinical Chemistry, Hematology, and Urinalysis Test Results | 0 Participants |
| 30 ng OLP-1002: Part A, Single Ascending Dose | Number of Participants With Findings of Clinical Importance in Clinical Chemistry, Hematology, and Urinalysis Test Results | 0 Participants |
| 120 ng OLP-1002: Part A, Single Ascending Dose | Number of Participants With Findings of Clinical Importance in Clinical Chemistry, Hematology, and Urinalysis Test Results | 0 Participants |
| 400 ng OLP-1002: Part A, Single Ascending Dose | Number of Participants With Findings of Clinical Importance in Clinical Chemistry, Hematology, and Urinalysis Test Results | 0 Participants |
| 1.2 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Findings of Clinical Importance in Clinical Chemistry, Hematology, and Urinalysis Test Results | 0 Participants |
| 3 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Findings of Clinical Importance in Clinical Chemistry, Hematology, and Urinalysis Test Results | 0 Participants |
| 6 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Findings of Clinical Importance in Clinical Chemistry, Hematology, and Urinalysis Test Results | 0 Participants |
| 12 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Findings of Clinical Importance in Clinical Chemistry, Hematology, and Urinalysis Test Results | 0 Participants |
| 20 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Findings of Clinical Importance in Clinical Chemistry, Hematology, and Urinalysis Test Results | 0 Participants |
| 40 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Findings of Clinical Importance in Clinical Chemistry, Hematology, and Urinalysis Test Results | 0 Participants |
| 80 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Findings of Clinical Importance in Clinical Chemistry, Hematology, and Urinalysis Test Results | 0 Participants |
| 160 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Findings of Clinical Importance in Clinical Chemistry, Hematology, and Urinalysis Test Results | 0 Participants |
| 5 x Placebo Part B, Multiple Ascending Dose | Number of Participants With Findings of Clinical Importance in Clinical Chemistry, Hematology, and Urinalysis Test Results | 0 Participants |
| 5 x 2 μg OLP-1002: Part B, Multiple Ascending Dose | Number of Participants With Findings of Clinical Importance in Clinical Chemistry, Hematology, and Urinalysis Test Results | 0 Participants |
| 5 x 5 μg OLP-1002: Part B, Multiple Ascending Dose | Number of Participants With Findings of Clinical Importance in Clinical Chemistry, Hematology, and Urinalysis Test Results | 0 Participants |
| 5 x 10 μg OLP-1002: Part B, Multiple Ascending Dose | Number of Participants With Findings of Clinical Importance in Clinical Chemistry, Hematology, and Urinalysis Test Results | 0 Participants |
| 5 x 20 μg OLP-1002: Part B, Multiple Ascending Dose | Number of Participants With Findings of Clinical Importance in Clinical Chemistry, Hematology, and Urinalysis Test Results | 0 Participants |
| 5 x 40 μg OLP-1002: Part B, Multiple Ascending Dose | Number of Participants With Findings of Clinical Importance in Clinical Chemistry, Hematology, and Urinalysis Test Results | 0 Participants |
| 5 x 80 μg OLP-1002: Part B, Multiple Ascending Dose | Number of Participants With Findings of Clinical Importance in Clinical Chemistry, Hematology, and Urinalysis Test Results | 0 Participants |
Primary
Number of Participants With Full and Symptom-Directed Physical Examination Results
A full physical examination and symptom-directed physical examinations were performed at specified timepoints.
Time frame: Part A: From screening through study completion, up to 32 days. Part B: From screening through study completion, up to 60 days.
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo Part A, Single Ascending Dose | Number of Participants With Full and Symptom-Directed Physical Examination Results | Medical device site rash (clinically significant, not related to study drug) | 0 Participants |
| Placebo Part A, Single Ascending Dose | Number of Participants With Full and Symptom-Directed Physical Examination Results | Papule (clinically significant, not related to study drug) | 0 Participants |
| Placebo Part A, Single Ascending Dose | Number of Participants With Full and Symptom-Directed Physical Examination Results | Tongue ulceration (clinically significant, not related to study drug) | 0 Participants |
| Placebo Part A, Single Ascending Dose | Number of Participants With Full and Symptom-Directed Physical Examination Results | Sunburn (clinically significant, not related to study drug) | 0 Participants |
| Placebo Part A, Single Ascending Dose | Number of Participants With Full and Symptom-Directed Physical Examination Results | Gingival swelling (clinically significant, not related to study drug) | 0 Participants |
| 30 ng OLP-1002: Part A, Single Ascending Dose | Number of Participants With Full and Symptom-Directed Physical Examination Results | Tongue ulceration (clinically significant, not related to study drug) | 0 Participants |
| 30 ng OLP-1002: Part A, Single Ascending Dose | Number of Participants With Full and Symptom-Directed Physical Examination Results | Sunburn (clinically significant, not related to study drug) | 0 Participants |
| 30 ng OLP-1002: Part A, Single Ascending Dose | Number of Participants With Full and Symptom-Directed Physical Examination Results | Gingival swelling (clinically significant, not related to study drug) | 0 Participants |
| 30 ng OLP-1002: Part A, Single Ascending Dose | Number of Participants With Full and Symptom-Directed Physical Examination Results | Medical device site rash (clinically significant, not related to study drug) | 0 Participants |
| 30 ng OLP-1002: Part A, Single Ascending Dose | Number of Participants With Full and Symptom-Directed Physical Examination Results | Papule (clinically significant, not related to study drug) | 0 Participants |
| 120 ng OLP-1002: Part A, Single Ascending Dose | Number of Participants With Full and Symptom-Directed Physical Examination Results | Medical device site rash (clinically significant, not related to study drug) | 1 Participants |
| 120 ng OLP-1002: Part A, Single Ascending Dose | Number of Participants With Full and Symptom-Directed Physical Examination Results | Tongue ulceration (clinically significant, not related to study drug) | 0 Participants |
| 120 ng OLP-1002: Part A, Single Ascending Dose | Number of Participants With Full and Symptom-Directed Physical Examination Results | Sunburn (clinically significant, not related to study drug) | 0 Participants |
| 120 ng OLP-1002: Part A, Single Ascending Dose | Number of Participants With Full and Symptom-Directed Physical Examination Results | Gingival swelling (clinically significant, not related to study drug) | 0 Participants |
| 120 ng OLP-1002: Part A, Single Ascending Dose | Number of Participants With Full and Symptom-Directed Physical Examination Results | Papule (clinically significant, not related to study drug) | 0 Participants |
| 400 ng OLP-1002: Part A, Single Ascending Dose | Number of Participants With Full and Symptom-Directed Physical Examination Results | Tongue ulceration (clinically significant, not related to study drug) | 0 Participants |
| 400 ng OLP-1002: Part A, Single Ascending Dose | Number of Participants With Full and Symptom-Directed Physical Examination Results | Medical device site rash (clinically significant, not related to study drug) | 0 Participants |
| 400 ng OLP-1002: Part A, Single Ascending Dose | Number of Participants With Full and Symptom-Directed Physical Examination Results | Gingival swelling (clinically significant, not related to study drug) | 0 Participants |
| 400 ng OLP-1002: Part A, Single Ascending Dose | Number of Participants With Full and Symptom-Directed Physical Examination Results | Sunburn (clinically significant, not related to study drug) | 0 Participants |
| 400 ng OLP-1002: Part A, Single Ascending Dose | Number of Participants With Full and Symptom-Directed Physical Examination Results | Papule (clinically significant, not related to study drug) | 0 Participants |
| 1.2 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Full and Symptom-Directed Physical Examination Results | Papule (clinically significant, not related to study drug) | 0 Participants |
| 1.2 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Full and Symptom-Directed Physical Examination Results | Medical device site rash (clinically significant, not related to study drug) | 0 Participants |
| 1.2 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Full and Symptom-Directed Physical Examination Results | Tongue ulceration (clinically significant, not related to study drug) | 0 Participants |
| 1.2 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Full and Symptom-Directed Physical Examination Results | Sunburn (clinically significant, not related to study drug) | 0 Participants |
| 1.2 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Full and Symptom-Directed Physical Examination Results | Gingival swelling (clinically significant, not related to study drug) | 0 Participants |
| 3 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Full and Symptom-Directed Physical Examination Results | Gingival swelling (clinically significant, not related to study drug) | 0 Participants |
| 3 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Full and Symptom-Directed Physical Examination Results | Papule (clinically significant, not related to study drug) | 0 Participants |
| 3 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Full and Symptom-Directed Physical Examination Results | Sunburn (clinically significant, not related to study drug) | 0 Participants |
| 3 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Full and Symptom-Directed Physical Examination Results | Tongue ulceration (clinically significant, not related to study drug) | 0 Participants |
| 3 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Full and Symptom-Directed Physical Examination Results | Medical device site rash (clinically significant, not related to study drug) | 0 Participants |
| 6 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Full and Symptom-Directed Physical Examination Results | Papule (clinically significant, not related to study drug) | 0 Participants |
| 6 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Full and Symptom-Directed Physical Examination Results | Sunburn (clinically significant, not related to study drug) | 1 Participants |
| 6 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Full and Symptom-Directed Physical Examination Results | Medical device site rash (clinically significant, not related to study drug) | 0 Participants |
| 6 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Full and Symptom-Directed Physical Examination Results | Gingival swelling (clinically significant, not related to study drug) | 0 Participants |
| 6 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Full and Symptom-Directed Physical Examination Results | Tongue ulceration (clinically significant, not related to study drug) | 0 Participants |
| 12 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Full and Symptom-Directed Physical Examination Results | Tongue ulceration (clinically significant, not related to study drug) | 0 Participants |
| 12 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Full and Symptom-Directed Physical Examination Results | Gingival swelling (clinically significant, not related to study drug) | 0 Participants |
| 12 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Full and Symptom-Directed Physical Examination Results | Papule (clinically significant, not related to study drug) | 0 Participants |
| 12 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Full and Symptom-Directed Physical Examination Results | Medical device site rash (clinically significant, not related to study drug) | 0 Participants |
| 12 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Full and Symptom-Directed Physical Examination Results | Sunburn (clinically significant, not related to study drug) | 0 Participants |
| 20 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Full and Symptom-Directed Physical Examination Results | Papule (clinically significant, not related to study drug) | 0 Participants |
| 20 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Full and Symptom-Directed Physical Examination Results | Medical device site rash (clinically significant, not related to study drug) | 0 Participants |
| 20 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Full and Symptom-Directed Physical Examination Results | Sunburn (clinically significant, not related to study drug) | 0 Participants |
| 20 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Full and Symptom-Directed Physical Examination Results | Gingival swelling (clinically significant, not related to study drug) | 0 Participants |
| 20 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Full and Symptom-Directed Physical Examination Results | Tongue ulceration (clinically significant, not related to study drug) | 0 Participants |
| 40 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Full and Symptom-Directed Physical Examination Results | Papule (clinically significant, not related to study drug) | 0 Participants |
| 40 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Full and Symptom-Directed Physical Examination Results | Medical device site rash (clinically significant, not related to study drug) | 0 Participants |
| 40 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Full and Symptom-Directed Physical Examination Results | Sunburn (clinically significant, not related to study drug) | 0 Participants |
| 40 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Full and Symptom-Directed Physical Examination Results | Tongue ulceration (clinically significant, not related to study drug) | 0 Participants |
| 40 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Full and Symptom-Directed Physical Examination Results | Gingival swelling (clinically significant, not related to study drug) | 0 Participants |
| 80 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Full and Symptom-Directed Physical Examination Results | Sunburn (clinically significant, not related to study drug) | 0 Participants |
| 80 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Full and Symptom-Directed Physical Examination Results | Medical device site rash (clinically significant, not related to study drug) | 0 Participants |
| 80 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Full and Symptom-Directed Physical Examination Results | Papule (clinically significant, not related to study drug) | 0 Participants |
| 80 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Full and Symptom-Directed Physical Examination Results | Tongue ulceration (clinically significant, not related to study drug) | 0 Participants |
| 80 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Full and Symptom-Directed Physical Examination Results | Gingival swelling (clinically significant, not related to study drug) | 0 Participants |
| 160 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Full and Symptom-Directed Physical Examination Results | Gingival swelling (clinically significant, not related to study drug) | 0 Participants |
| 160 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Full and Symptom-Directed Physical Examination Results | Sunburn (clinically significant, not related to study drug) | 0 Participants |
| 160 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Full and Symptom-Directed Physical Examination Results | Medical device site rash (clinically significant, not related to study drug) | 0 Participants |
| 160 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Full and Symptom-Directed Physical Examination Results | Tongue ulceration (clinically significant, not related to study drug) | 0 Participants |
| 160 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Full and Symptom-Directed Physical Examination Results | Papule (clinically significant, not related to study drug) | 0 Participants |
| 5 x Placebo Part B, Multiple Ascending Dose | Number of Participants With Full and Symptom-Directed Physical Examination Results | Medical device site rash (clinically significant, not related to study drug) | 0 Participants |
| 5 x Placebo Part B, Multiple Ascending Dose | Number of Participants With Full and Symptom-Directed Physical Examination Results | Gingival swelling (clinically significant, not related to study drug) | 0 Participants |
| 5 x Placebo Part B, Multiple Ascending Dose | Number of Participants With Full and Symptom-Directed Physical Examination Results | Sunburn (clinically significant, not related to study drug) | 0 Participants |
| 5 x Placebo Part B, Multiple Ascending Dose | Number of Participants With Full and Symptom-Directed Physical Examination Results | Tongue ulceration (clinically significant, not related to study drug) | 0 Participants |
| 5 x Placebo Part B, Multiple Ascending Dose | Number of Participants With Full and Symptom-Directed Physical Examination Results | Papule (clinically significant, not related to study drug) | 0 Participants |
| 5 x 2 μg OLP-1002: Part B, Multiple Ascending Dose | Number of Participants With Full and Symptom-Directed Physical Examination Results | Tongue ulceration (clinically significant, not related to study drug) | 0 Participants |
| 5 x 2 μg OLP-1002: Part B, Multiple Ascending Dose | Number of Participants With Full and Symptom-Directed Physical Examination Results | Papule (clinically significant, not related to study drug) | 1 Participants |
| 5 x 2 μg OLP-1002: Part B, Multiple Ascending Dose | Number of Participants With Full and Symptom-Directed Physical Examination Results | Sunburn (clinically significant, not related to study drug) | 0 Participants |
| 5 x 2 μg OLP-1002: Part B, Multiple Ascending Dose | Number of Participants With Full and Symptom-Directed Physical Examination Results | Medical device site rash (clinically significant, not related to study drug) | 0 Participants |
| 5 x 2 μg OLP-1002: Part B, Multiple Ascending Dose | Number of Participants With Full and Symptom-Directed Physical Examination Results | Gingival swelling (clinically significant, not related to study drug) | 0 Participants |
| 5 x 5 μg OLP-1002: Part B, Multiple Ascending Dose | Number of Participants With Full and Symptom-Directed Physical Examination Results | Sunburn (clinically significant, not related to study drug) | 0 Participants |
| 5 x 5 μg OLP-1002: Part B, Multiple Ascending Dose | Number of Participants With Full and Symptom-Directed Physical Examination Results | Gingival swelling (clinically significant, not related to study drug) | 0 Participants |
| 5 x 5 μg OLP-1002: Part B, Multiple Ascending Dose | Number of Participants With Full and Symptom-Directed Physical Examination Results | Medical device site rash (clinically significant, not related to study drug) | 0 Participants |
| 5 x 5 μg OLP-1002: Part B, Multiple Ascending Dose | Number of Participants With Full and Symptom-Directed Physical Examination Results | Tongue ulceration (clinically significant, not related to study drug) | 1 Participants |
| 5 x 5 μg OLP-1002: Part B, Multiple Ascending Dose | Number of Participants With Full and Symptom-Directed Physical Examination Results | Papule (clinically significant, not related to study drug) | 0 Participants |
| 5 x 10 μg OLP-1002: Part B, Multiple Ascending Dose | Number of Participants With Full and Symptom-Directed Physical Examination Results | Tongue ulceration (clinically significant, not related to study drug) | 0 Participants |
| 5 x 10 μg OLP-1002: Part B, Multiple Ascending Dose | Number of Participants With Full and Symptom-Directed Physical Examination Results | Papule (clinically significant, not related to study drug) | 0 Participants |
| 5 x 10 μg OLP-1002: Part B, Multiple Ascending Dose | Number of Participants With Full and Symptom-Directed Physical Examination Results | Sunburn (clinically significant, not related to study drug) | 0 Participants |
| 5 x 10 μg OLP-1002: Part B, Multiple Ascending Dose | Number of Participants With Full and Symptom-Directed Physical Examination Results | Medical device site rash (clinically significant, not related to study drug) | 0 Participants |
| 5 x 10 μg OLP-1002: Part B, Multiple Ascending Dose | Number of Participants With Full and Symptom-Directed Physical Examination Results | Gingival swelling (clinically significant, not related to study drug) | 1 Participants |
| 5 x 20 μg OLP-1002: Part B, Multiple Ascending Dose | Number of Participants With Full and Symptom-Directed Physical Examination Results | Papule (clinically significant, not related to study drug) | 0 Participants |
| 5 x 20 μg OLP-1002: Part B, Multiple Ascending Dose | Number of Participants With Full and Symptom-Directed Physical Examination Results | Gingival swelling (clinically significant, not related to study drug) | 0 Participants |
| 5 x 20 μg OLP-1002: Part B, Multiple Ascending Dose | Number of Participants With Full and Symptom-Directed Physical Examination Results | Sunburn (clinically significant, not related to study drug) | 0 Participants |
| 5 x 20 μg OLP-1002: Part B, Multiple Ascending Dose | Number of Participants With Full and Symptom-Directed Physical Examination Results | Medical device site rash (clinically significant, not related to study drug) | 0 Participants |
| 5 x 20 μg OLP-1002: Part B, Multiple Ascending Dose | Number of Participants With Full and Symptom-Directed Physical Examination Results | Tongue ulceration (clinically significant, not related to study drug) | 0 Participants |
| 5 x 40 μg OLP-1002: Part B, Multiple Ascending Dose | Number of Participants With Full and Symptom-Directed Physical Examination Results | Papule (clinically significant, not related to study drug) | 0 Participants |
| 5 x 40 μg OLP-1002: Part B, Multiple Ascending Dose | Number of Participants With Full and Symptom-Directed Physical Examination Results | Tongue ulceration (clinically significant, not related to study drug) | 0 Participants |
| 5 x 40 μg OLP-1002: Part B, Multiple Ascending Dose | Number of Participants With Full and Symptom-Directed Physical Examination Results | Gingival swelling (clinically significant, not related to study drug) | 0 Participants |
| 5 x 40 μg OLP-1002: Part B, Multiple Ascending Dose | Number of Participants With Full and Symptom-Directed Physical Examination Results | Sunburn (clinically significant, not related to study drug) | 0 Participants |
| 5 x 40 μg OLP-1002: Part B, Multiple Ascending Dose | Number of Participants With Full and Symptom-Directed Physical Examination Results | Medical device site rash (clinically significant, not related to study drug) | 0 Participants |
| 5 x 80 μg OLP-1002: Part B, Multiple Ascending Dose | Number of Participants With Full and Symptom-Directed Physical Examination Results | Papule (clinically significant, not related to study drug) | 0 Participants |
| 5 x 80 μg OLP-1002: Part B, Multiple Ascending Dose | Number of Participants With Full and Symptom-Directed Physical Examination Results | Gingival swelling (clinically significant, not related to study drug) | 0 Participants |
| 5 x 80 μg OLP-1002: Part B, Multiple Ascending Dose | Number of Participants With Full and Symptom-Directed Physical Examination Results | Tongue ulceration (clinically significant, not related to study drug) | 0 Participants |
| 5 x 80 μg OLP-1002: Part B, Multiple Ascending Dose | Number of Participants With Full and Symptom-Directed Physical Examination Results | Medical device site rash (clinically significant, not related to study drug) | 0 Participants |
| 5 x 80 μg OLP-1002: Part B, Multiple Ascending Dose | Number of Participants With Full and Symptom-Directed Physical Examination Results | Sunburn (clinically significant, not related to study drug) | 0 Participants |
Primary
Number of Participants With Injection Site Assessment Results
Evaluation of the dosing site for the following: Pain: Grade 0 to 4 Redness (assessed by estimating the size of the red patch at the injection site across its widest point): Grade 0: 0-24 mm; Grade 1: 25-50 mm; Grade 2: 51-100 mm; Grade 3: More than 100 mm; Grade 4: Requires medical intervention greater than analgesia Swelling (assessed by estimating the size of the raised area around the injection site across its widest point): Grade 0: 0-24 mm; Grade 1: 25-50 mm and does not interfere with activity; Grade 2: 51-100 mm or interferes with activity; Grade 3: More than 100 mm and prevents daily activity; Grade 4: Requires medical intervention greater than analgesia Tenderness: Grade 0 to 4 Bruising and ulceration were evaluated as present or absent.
Time frame: Part A: From screening through study completion, up to 32 days. Part B: From screening through study completion, up to 60 days.
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo Part A, Single Ascending Dose | Number of Participants With Injection Site Assessment Results | Swelling : Grade 2 (51-100 mm or interferes with activity) | 0 Participants |
| Placebo Part A, Single Ascending Dose | Number of Participants With Injection Site Assessment Results | Tenderness : Grade 2 (moderate pain to touch) | 0 Participants |
| Placebo Part A, Single Ascending Dose | Number of Participants With Injection Site Assessment Results | Swelling : Grade 1 (25-50 mm) | 0 Participants |
| Placebo Part A, Single Ascending Dose | Number of Participants With Injection Site Assessment Results | Pain : Grade 1 (does not interfere with activity) | 0 Participants |
| Placebo Part A, Single Ascending Dose | Number of Participants With Injection Site Assessment Results | Bruising : Present | 1 Participants |
| Placebo Part A, Single Ascending Dose | Number of Participants With Injection Site Assessment Results | Redness : Grade 2 (51-100 mm) | 0 Participants |
| Placebo Part A, Single Ascending Dose | Number of Participants With Injection Site Assessment Results | Pain : Grade 2 (interferes with activity or repeated use of non-narcotic pain reliever) | 0 Participants |
| Placebo Part A, Single Ascending Dose | Number of Participants With Injection Site Assessment Results | Tenderness : Grade 1 (mild pain to touch) | 0 Participants |
| Placebo Part A, Single Ascending Dose | Number of Participants With Injection Site Assessment Results | Redness : Grade 1 (25-50 mm) | 0 Participants |
| 30 ng OLP-1002: Part A, Single Ascending Dose | Number of Participants With Injection Site Assessment Results | Pain : Grade 1 (does not interfere with activity) | 0 Participants |
| 30 ng OLP-1002: Part A, Single Ascending Dose | Number of Participants With Injection Site Assessment Results | Pain : Grade 2 (interferes with activity or repeated use of non-narcotic pain reliever) | 0 Participants |
| 30 ng OLP-1002: Part A, Single Ascending Dose | Number of Participants With Injection Site Assessment Results | Swelling : Grade 1 (25-50 mm) | 0 Participants |
| 30 ng OLP-1002: Part A, Single Ascending Dose | Number of Participants With Injection Site Assessment Results | Bruising : Present | 0 Participants |
| 30 ng OLP-1002: Part A, Single Ascending Dose | Number of Participants With Injection Site Assessment Results | Redness : Grade 2 (51-100 mm) | 0 Participants |
| 30 ng OLP-1002: Part A, Single Ascending Dose | Number of Participants With Injection Site Assessment Results | Redness : Grade 1 (25-50 mm) | 0 Participants |
| 30 ng OLP-1002: Part A, Single Ascending Dose | Number of Participants With Injection Site Assessment Results | Swelling : Grade 2 (51-100 mm or interferes with activity) | 0 Participants |
| 30 ng OLP-1002: Part A, Single Ascending Dose | Number of Participants With Injection Site Assessment Results | Tenderness : Grade 2 (moderate pain to touch) | 0 Participants |
| 30 ng OLP-1002: Part A, Single Ascending Dose | Number of Participants With Injection Site Assessment Results | Tenderness : Grade 1 (mild pain to touch) | 0 Participants |
| 120 ng OLP-1002: Part A, Single Ascending Dose | Number of Participants With Injection Site Assessment Results | Redness : Grade 1 (25-50 mm) | 0 Participants |
| 120 ng OLP-1002: Part A, Single Ascending Dose | Number of Participants With Injection Site Assessment Results | Pain : Grade 1 (does not interfere with activity) | 0 Participants |
| 120 ng OLP-1002: Part A, Single Ascending Dose | Number of Participants With Injection Site Assessment Results | Tenderness : Grade 2 (moderate pain to touch) | 0 Participants |
| 120 ng OLP-1002: Part A, Single Ascending Dose | Number of Participants With Injection Site Assessment Results | Swelling : Grade 1 (25-50 mm) | 0 Participants |
| 120 ng OLP-1002: Part A, Single Ascending Dose | Number of Participants With Injection Site Assessment Results | Redness : Grade 2 (51-100 mm) | 0 Participants |
| 120 ng OLP-1002: Part A, Single Ascending Dose | Number of Participants With Injection Site Assessment Results | Bruising : Present | 0 Participants |
| 120 ng OLP-1002: Part A, Single Ascending Dose | Number of Participants With Injection Site Assessment Results | Tenderness : Grade 1 (mild pain to touch) | 0 Participants |
| 120 ng OLP-1002: Part A, Single Ascending Dose | Number of Participants With Injection Site Assessment Results | Pain : Grade 2 (interferes with activity or repeated use of non-narcotic pain reliever) | 0 Participants |
| 120 ng OLP-1002: Part A, Single Ascending Dose | Number of Participants With Injection Site Assessment Results | Swelling : Grade 2 (51-100 mm or interferes with activity) | 0 Participants |
| 400 ng OLP-1002: Part A, Single Ascending Dose | Number of Participants With Injection Site Assessment Results | Pain : Grade 1 (does not interfere with activity) | 0 Participants |
| 400 ng OLP-1002: Part A, Single Ascending Dose | Number of Participants With Injection Site Assessment Results | Redness : Grade 2 (51-100 mm) | 0 Participants |
| 400 ng OLP-1002: Part A, Single Ascending Dose | Number of Participants With Injection Site Assessment Results | Bruising : Present | 0 Participants |
| 400 ng OLP-1002: Part A, Single Ascending Dose | Number of Participants With Injection Site Assessment Results | Pain : Grade 2 (interferes with activity or repeated use of non-narcotic pain reliever) | 0 Participants |
| 400 ng OLP-1002: Part A, Single Ascending Dose | Number of Participants With Injection Site Assessment Results | Swelling : Grade 2 (51-100 mm or interferes with activity) | 0 Participants |
| 400 ng OLP-1002: Part A, Single Ascending Dose | Number of Participants With Injection Site Assessment Results | Swelling : Grade 1 (25-50 mm) | 0 Participants |
| 400 ng OLP-1002: Part A, Single Ascending Dose | Number of Participants With Injection Site Assessment Results | Tenderness : Grade 1 (mild pain to touch) | 0 Participants |
| 400 ng OLP-1002: Part A, Single Ascending Dose | Number of Participants With Injection Site Assessment Results | Tenderness : Grade 2 (moderate pain to touch) | 0 Participants |
| 400 ng OLP-1002: Part A, Single Ascending Dose | Number of Participants With Injection Site Assessment Results | Redness : Grade 1 (25-50 mm) | 0 Participants |
| 1.2 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Injection Site Assessment Results | Redness : Grade 1 (25-50 mm) | 0 Participants |
| 1.2 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Injection Site Assessment Results | Tenderness : Grade 2 (moderate pain to touch) | 0 Participants |
| 1.2 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Injection Site Assessment Results | Redness : Grade 2 (51-100 mm) | 0 Participants |
| 1.2 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Injection Site Assessment Results | Bruising : Present | 0 Participants |
| 1.2 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Injection Site Assessment Results | Pain : Grade 2 (interferes with activity or repeated use of non-narcotic pain reliever) | 0 Participants |
| 1.2 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Injection Site Assessment Results | Swelling : Grade 2 (51-100 mm or interferes with activity) | 0 Participants |
| 1.2 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Injection Site Assessment Results | Pain : Grade 1 (does not interfere with activity) | 0 Participants |
| 1.2 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Injection Site Assessment Results | Tenderness : Grade 1 (mild pain to touch) | 0 Participants |
| 1.2 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Injection Site Assessment Results | Swelling : Grade 1 (25-50 mm) | 0 Participants |
| 3 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Injection Site Assessment Results | Pain : Grade 1 (does not interfere with activity) | 0 Participants |
| 3 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Injection Site Assessment Results | Redness : Grade 1 (25-50 mm) | 0 Participants |
| 3 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Injection Site Assessment Results | Pain : Grade 2 (interferes with activity or repeated use of non-narcotic pain reliever) | 0 Participants |
| 3 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Injection Site Assessment Results | Swelling : Grade 2 (51-100 mm or interferes with activity) | 0 Participants |
| 3 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Injection Site Assessment Results | Redness : Grade 2 (51-100 mm) | 0 Participants |
| 3 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Injection Site Assessment Results | Tenderness : Grade 1 (mild pain to touch) | 0 Participants |
| 3 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Injection Site Assessment Results | Bruising : Present | 0 Participants |
| 3 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Injection Site Assessment Results | Tenderness : Grade 2 (moderate pain to touch) | 0 Participants |
| 3 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Injection Site Assessment Results | Swelling : Grade 1 (25-50 mm) | 0 Participants |
| 6 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Injection Site Assessment Results | Tenderness : Grade 1 (mild pain to touch) | 0 Participants |
| 6 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Injection Site Assessment Results | Pain : Grade 1 (does not interfere with activity) | 0 Participants |
| 6 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Injection Site Assessment Results | Bruising : Present | 0 Participants |
| 6 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Injection Site Assessment Results | Swelling : Grade 2 (51-100 mm or interferes with activity) | 0 Participants |
| 6 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Injection Site Assessment Results | Pain : Grade 2 (interferes with activity or repeated use of non-narcotic pain reliever) | 0 Participants |
| 6 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Injection Site Assessment Results | Swelling : Grade 1 (25-50 mm) | 0 Participants |
| 6 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Injection Site Assessment Results | Redness : Grade 2 (51-100 mm) | 0 Participants |
| 6 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Injection Site Assessment Results | Tenderness : Grade 2 (moderate pain to touch) | 0 Participants |
| 6 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Injection Site Assessment Results | Redness : Grade 1 (25-50 mm) | 0 Participants |
| 12 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Injection Site Assessment Results | Swelling : Grade 1 (25-50 mm) | 0 Participants |
| 12 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Injection Site Assessment Results | Pain : Grade 1 (does not interfere with activity) | 1 Participants |
| 12 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Injection Site Assessment Results | Tenderness : Grade 2 (moderate pain to touch) | 0 Participants |
| 12 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Injection Site Assessment Results | Pain : Grade 2 (interferes with activity or repeated use of non-narcotic pain reliever) | 0 Participants |
| 12 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Injection Site Assessment Results | Swelling : Grade 2 (51-100 mm or interferes with activity) | 0 Participants |
| 12 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Injection Site Assessment Results | Bruising : Present | 0 Participants |
| 12 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Injection Site Assessment Results | Redness : Grade 1 (25-50 mm) | 0 Participants |
| 12 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Injection Site Assessment Results | Redness : Grade 2 (51-100 mm) | 0 Participants |
| 12 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Injection Site Assessment Results | Tenderness : Grade 1 (mild pain to touch) | 0 Participants |
| 20 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Injection Site Assessment Results | Redness : Grade 1 (25-50 mm) | 0 Participants |
| 20 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Injection Site Assessment Results | Pain : Grade 1 (does not interfere with activity) | 1 Participants |
| 20 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Injection Site Assessment Results | Pain : Grade 2 (interferes with activity or repeated use of non-narcotic pain reliever) | 0 Participants |
| 20 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Injection Site Assessment Results | Tenderness : Grade 1 (mild pain to touch) | 1 Participants |
| 20 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Injection Site Assessment Results | Tenderness : Grade 2 (moderate pain to touch) | 0 Participants |
| 20 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Injection Site Assessment Results | Redness : Grade 2 (51-100 mm) | 0 Participants |
| 20 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Injection Site Assessment Results | Swelling : Grade 1 (25-50 mm) | 0 Participants |
| 20 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Injection Site Assessment Results | Swelling : Grade 2 (51-100 mm or interferes with activity) | 0 Participants |
| 20 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Injection Site Assessment Results | Bruising : Present | 1 Participants |
| 40 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Injection Site Assessment Results | Pain : Grade 1 (does not interfere with activity) | 0 Participants |
| 40 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Injection Site Assessment Results | Swelling : Grade 2 (51-100 mm or interferes with activity) | 0 Participants |
| 40 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Injection Site Assessment Results | Swelling : Grade 1 (25-50 mm) | 0 Participants |
| 40 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Injection Site Assessment Results | Pain : Grade 2 (interferes with activity or repeated use of non-narcotic pain reliever) | 0 Participants |
| 40 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Injection Site Assessment Results | Redness : Grade 2 (51-100 mm) | 0 Participants |
| 40 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Injection Site Assessment Results | Tenderness : Grade 1 (mild pain to touch) | 0 Participants |
| 40 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Injection Site Assessment Results | Redness : Grade 1 (25-50 mm) | 0 Participants |
| 40 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Injection Site Assessment Results | Tenderness : Grade 2 (moderate pain to touch) | 0 Participants |
| 40 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Injection Site Assessment Results | Bruising : Present | 1 Participants |
| 80 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Injection Site Assessment Results | Bruising : Present | 0 Participants |
| 80 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Injection Site Assessment Results | Tenderness : Grade 2 (moderate pain to touch) | 1 Participants |
| 80 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Injection Site Assessment Results | Pain : Grade 2 (interferes with activity or repeated use of non-narcotic pain reliever) | 0 Participants |
| 80 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Injection Site Assessment Results | Swelling : Grade 1 (25-50 mm) | 0 Participants |
| 80 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Injection Site Assessment Results | Redness : Grade 1 (25-50 mm) | 0 Participants |
| 80 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Injection Site Assessment Results | Swelling : Grade 2 (51-100 mm or interferes with activity) | 0 Participants |
| 80 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Injection Site Assessment Results | Pain : Grade 1 (does not interfere with activity) | 0 Participants |
| 80 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Injection Site Assessment Results | Redness : Grade 2 (51-100 mm) | 0 Participants |
| 80 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Injection Site Assessment Results | Tenderness : Grade 1 (mild pain to touch) | 2 Participants |
| 160 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Injection Site Assessment Results | Redness : Grade 2 (51-100 mm) | 0 Participants |
| 160 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Injection Site Assessment Results | Tenderness : Grade 2 (moderate pain to touch) | 0 Participants |
| 160 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Injection Site Assessment Results | Swelling : Grade 2 (51-100 mm or interferes with activity) | 0 Participants |
| 160 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Injection Site Assessment Results | Tenderness : Grade 1 (mild pain to touch) | 1 Participants |
| 160 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Injection Site Assessment Results | Pain : Grade 2 (interferes with activity or repeated use of non-narcotic pain reliever) | 0 Participants |
| 160 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Injection Site Assessment Results | Bruising : Present | 0 Participants |
| 160 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Injection Site Assessment Results | Pain : Grade 1 (does not interfere with activity) | 0 Participants |
| 160 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Injection Site Assessment Results | Redness : Grade 1 (25-50 mm) | 0 Participants |
| 160 µg OLP-1002: Part A, Single Ascending Dose | Number of Participants With Injection Site Assessment Results | Swelling : Grade 1 (25-50 mm) | 0 Participants |
| 5 x Placebo Part B, Multiple Ascending Dose | Number of Participants With Injection Site Assessment Results | Redness : Grade 2 (51-100 mm) | 0 Participants |
| 5 x Placebo Part B, Multiple Ascending Dose | Number of Participants With Injection Site Assessment Results | Swelling : Grade 1 (25-50 mm) | 0 Participants |
| 5 x Placebo Part B, Multiple Ascending Dose | Number of Participants With Injection Site Assessment Results | Pain : Grade 2 (interferes with activity or repeated use of non-narcotic pain reliever) | 0 Participants |
| 5 x Placebo Part B, Multiple Ascending Dose | Number of Participants With Injection Site Assessment Results | Redness : Grade 1 (25-50 mm) | 1 Participants |
| 5 x Placebo Part B, Multiple Ascending Dose | Number of Participants With Injection Site Assessment Results | Bruising : Present | 0 Participants |
| 5 x Placebo Part B, Multiple Ascending Dose | Number of Participants With Injection Site Assessment Results | Tenderness : Grade 2 (moderate pain to touch) | 0 Participants |
| 5 x Placebo Part B, Multiple Ascending Dose | Number of Participants With Injection Site Assessment Results | Tenderness : Grade 1 (mild pain to touch) | 0 Participants |
| 5 x Placebo Part B, Multiple Ascending Dose | Number of Participants With Injection Site Assessment Results | Pain : Grade 1 (does not interfere with activity) | 0 Participants |
| 5 x Placebo Part B, Multiple Ascending Dose | Number of Participants With Injection Site Assessment Results | Swelling : Grade 2 (51-100 mm or interferes with activity) | 0 Participants |
| 5 x 2 μg OLP-1002: Part B, Multiple Ascending Dose | Number of Participants With Injection Site Assessment Results | Swelling : Grade 2 (51-100 mm or interferes with activity) | 0 Participants |
| 5 x 2 μg OLP-1002: Part B, Multiple Ascending Dose | Number of Participants With Injection Site Assessment Results | Pain : Grade 1 (does not interfere with activity) | 0 Participants |
| 5 x 2 μg OLP-1002: Part B, Multiple Ascending Dose | Number of Participants With Injection Site Assessment Results | Redness : Grade 2 (51-100 mm) | 0 Participants |
| 5 x 2 μg OLP-1002: Part B, Multiple Ascending Dose | Number of Participants With Injection Site Assessment Results | Tenderness : Grade 1 (mild pain to touch) | 0 Participants |
| 5 x 2 μg OLP-1002: Part B, Multiple Ascending Dose | Number of Participants With Injection Site Assessment Results | Bruising : Present | 1 Participants |
| 5 x 2 μg OLP-1002: Part B, Multiple Ascending Dose | Number of Participants With Injection Site Assessment Results | Tenderness : Grade 2 (moderate pain to touch) | 0 Participants |
| 5 x 2 μg OLP-1002: Part B, Multiple Ascending Dose | Number of Participants With Injection Site Assessment Results | Redness : Grade 1 (25-50 mm) | 0 Participants |
| 5 x 2 μg OLP-1002: Part B, Multiple Ascending Dose | Number of Participants With Injection Site Assessment Results | Pain : Grade 2 (interferes with activity or repeated use of non-narcotic pain reliever) | 0 Participants |
| 5 x 2 μg OLP-1002: Part B, Multiple Ascending Dose | Number of Participants With Injection Site Assessment Results | Swelling : Grade 1 (25-50 mm) | 0 Participants |
| 5 x 5 μg OLP-1002: Part B, Multiple Ascending Dose | Number of Participants With Injection Site Assessment Results | Swelling : Grade 2 (51-100 mm or interferes with activity) | 0 Participants |
| 5 x 5 μg OLP-1002: Part B, Multiple Ascending Dose | Number of Participants With Injection Site Assessment Results | Redness : Grade 1 (25-50 mm) | 0 Participants |
| 5 x 5 μg OLP-1002: Part B, Multiple Ascending Dose | Number of Participants With Injection Site Assessment Results | Tenderness : Grade 1 (mild pain to touch) | 1 Participants |
| 5 x 5 μg OLP-1002: Part B, Multiple Ascending Dose | Number of Participants With Injection Site Assessment Results | Redness : Grade 2 (51-100 mm) | 0 Participants |
| 5 x 5 μg OLP-1002: Part B, Multiple Ascending Dose | Number of Participants With Injection Site Assessment Results | Pain : Grade 2 (interferes with activity or repeated use of non-narcotic pain reliever) | 0 Participants |
| 5 x 5 μg OLP-1002: Part B, Multiple Ascending Dose | Number of Participants With Injection Site Assessment Results | Swelling : Grade 1 (25-50 mm) | 1 Participants |
| 5 x 5 μg OLP-1002: Part B, Multiple Ascending Dose | Number of Participants With Injection Site Assessment Results | Tenderness : Grade 2 (moderate pain to touch) | 0 Participants |
| 5 x 5 μg OLP-1002: Part B, Multiple Ascending Dose | Number of Participants With Injection Site Assessment Results | Pain : Grade 1 (does not interfere with activity) | 0 Participants |
| 5 x 5 μg OLP-1002: Part B, Multiple Ascending Dose | Number of Participants With Injection Site Assessment Results | Bruising : Present | 3 Participants |
| 5 x 10 μg OLP-1002: Part B, Multiple Ascending Dose | Number of Participants With Injection Site Assessment Results | Swelling : Grade 1 (25-50 mm) | 0 Participants |
| 5 x 10 μg OLP-1002: Part B, Multiple Ascending Dose | Number of Participants With Injection Site Assessment Results | Pain : Grade 2 (interferes with activity or repeated use of non-narcotic pain reliever) | 0 Participants |
| 5 x 10 μg OLP-1002: Part B, Multiple Ascending Dose | Number of Participants With Injection Site Assessment Results | Swelling : Grade 2 (51-100 mm or interferes with activity) | 0 Participants |
| 5 x 10 μg OLP-1002: Part B, Multiple Ascending Dose | Number of Participants With Injection Site Assessment Results | Pain : Grade 1 (does not interfere with activity) | 0 Participants |
| 5 x 10 μg OLP-1002: Part B, Multiple Ascending Dose | Number of Participants With Injection Site Assessment Results | Redness : Grade 2 (51-100 mm) | 0 Participants |
| 5 x 10 μg OLP-1002: Part B, Multiple Ascending Dose | Number of Participants With Injection Site Assessment Results | Bruising : Present | 1 Participants |
| 5 x 10 μg OLP-1002: Part B, Multiple Ascending Dose | Number of Participants With Injection Site Assessment Results | Tenderness : Grade 1 (mild pain to touch) | 0 Participants |
| 5 x 10 μg OLP-1002: Part B, Multiple Ascending Dose | Number of Participants With Injection Site Assessment Results | Redness : Grade 1 (25-50 mm) | 0 Participants |
| 5 x 10 μg OLP-1002: Part B, Multiple Ascending Dose | Number of Participants With Injection Site Assessment Results | Tenderness : Grade 2 (moderate pain to touch) | 0 Participants |
| 5 x 20 μg OLP-1002: Part B, Multiple Ascending Dose | Number of Participants With Injection Site Assessment Results | Bruising : Present | 0 Participants |
| 5 x 20 μg OLP-1002: Part B, Multiple Ascending Dose | Number of Participants With Injection Site Assessment Results | Tenderness : Grade 2 (moderate pain to touch) | 0 Participants |
| 5 x 20 μg OLP-1002: Part B, Multiple Ascending Dose | Number of Participants With Injection Site Assessment Results | Swelling : Grade 1 (25-50 mm) | 0 Participants |
| 5 x 20 μg OLP-1002: Part B, Multiple Ascending Dose | Number of Participants With Injection Site Assessment Results | Tenderness : Grade 1 (mild pain to touch) | 0 Participants |
| 5 x 20 μg OLP-1002: Part B, Multiple Ascending Dose | Number of Participants With Injection Site Assessment Results | Pain : Grade 1 (does not interfere with activity) | 0 Participants |
| 5 x 20 μg OLP-1002: Part B, Multiple Ascending Dose | Number of Participants With Injection Site Assessment Results | Redness : Grade 1 (25-50 mm) | 0 Participants |
| 5 x 20 μg OLP-1002: Part B, Multiple Ascending Dose | Number of Participants With Injection Site Assessment Results | Swelling : Grade 2 (51-100 mm or interferes with activity) | 0 Participants |
| 5 x 20 μg OLP-1002: Part B, Multiple Ascending Dose | Number of Participants With Injection Site Assessment Results | Redness : Grade 2 (51-100 mm) | 0 Participants |
| 5 x 20 μg OLP-1002: Part B, Multiple Ascending Dose | Number of Participants With Injection Site Assessment Results | Pain : Grade 2 (interferes with activity or repeated use of non-narcotic pain reliever) | 0 Participants |
| 5 x 40 μg OLP-1002: Part B, Multiple Ascending Dose | Number of Participants With Injection Site Assessment Results | Pain : Grade 2 (interferes with activity or repeated use of non-narcotic pain reliever) | 0 Participants |
| 5 x 40 μg OLP-1002: Part B, Multiple Ascending Dose | Number of Participants With Injection Site Assessment Results | Redness : Grade 2 (51-100 mm) | 0 Participants |
| 5 x 40 μg OLP-1002: Part B, Multiple Ascending Dose | Number of Participants With Injection Site Assessment Results | Tenderness : Grade 2 (moderate pain to touch) | 0 Participants |
| 5 x 40 μg OLP-1002: Part B, Multiple Ascending Dose | Number of Participants With Injection Site Assessment Results | Swelling : Grade 2 (51-100 mm or interferes with activity) | 0 Participants |
| 5 x 40 μg OLP-1002: Part B, Multiple Ascending Dose | Number of Participants With Injection Site Assessment Results | Swelling : Grade 1 (25-50 mm) | 0 Participants |
| 5 x 40 μg OLP-1002: Part B, Multiple Ascending Dose | Number of Participants With Injection Site Assessment Results | Tenderness : Grade 1 (mild pain to touch) | 1 Participants |
| 5 x 40 μg OLP-1002: Part B, Multiple Ascending Dose | Number of Participants With Injection Site Assessment Results | Redness : Grade 1 (25-50 mm) | 0 Participants |
| 5 x 40 μg OLP-1002: Part B, Multiple Ascending Dose | Number of Participants With Injection Site Assessment Results | Pain : Grade 1 (does not interfere with activity) | 1 Participants |
| 5 x 40 μg OLP-1002: Part B, Multiple Ascending Dose | Number of Participants With Injection Site Assessment Results | Bruising : Present | 3 Participants |
| 5 x 80 μg OLP-1002: Part B, Multiple Ascending Dose | Number of Participants With Injection Site Assessment Results | Redness : Grade 1 (25-50 mm) | 0 Participants |
| 5 x 80 μg OLP-1002: Part B, Multiple Ascending Dose | Number of Participants With Injection Site Assessment Results | Swelling : Grade 1 (25-50 mm) | 0 Participants |
| 5 x 80 μg OLP-1002: Part B, Multiple Ascending Dose | Number of Participants With Injection Site Assessment Results | Redness : Grade 2 (51-100 mm) | 0 Participants |
| 5 x 80 μg OLP-1002: Part B, Multiple Ascending Dose | Number of Participants With Injection Site Assessment Results | Swelling : Grade 2 (51-100 mm or interferes with activity) | 0 Participants |
| 5 x 80 μg OLP-1002: Part B, Multiple Ascending Dose | Number of Participants With Injection Site Assessment Results | Pain : Grade 1 (does not interfere with activity) | 0 Participants |
| 5 x 80 μg OLP-1002: Part B, Multiple Ascending Dose | Number of Participants With Injection Site Assessment Results | Tenderness : Grade 2 (moderate pain to touch) | 0 Participants |
| 5 x 80 μg OLP-1002: Part B, Multiple Ascending Dose | Number of Participants With Injection Site Assessment Results | Pain : Grade 2 (interferes with activity or repeated use of non-narcotic pain reliever) | 0 Participants |
| 5 x 80 μg OLP-1002: Part B, Multiple Ascending Dose | Number of Participants With Injection Site Assessment Results | Bruising : Present | 1 Participants |
| 5 x 80 μg OLP-1002: Part B, Multiple Ascending Dose | Number of Participants With Injection Site Assessment Results | Tenderness : Grade 1 (mild pain to touch) | 0 Participants |